Argon Medical Devices, Inc
Wheeling, IL, US
ARGON MEDICAL DEVICES INC. appears in FDA device records in Wheeling, IL. FDA records list 64 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 145 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Argon Medical Devices, Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Angiotech (Manan Medical Products, Inc.)enforcement report, recall
- Manan Medical Products, Inc.510(k), recall
510(k) clearance history
Showing 50 of 64FDA records hold 64 510(k) clearances for Argon Medical Devices, Inc between 1988 and 2026. The busiest year on record is 1996, with 9. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 3 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 5 |
| 1995 | 4 |
| 1996 | 9 |
| 1997 | 4 |
| 1998 | 4 |
| 1999 | 1 |
| 2001 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 4 |
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 4 |
| 2025 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252795 | ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial | KNW | Substantially Equivalent | |
| K260028 | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister | QEW | Substantially Equivalent | |
| K251318 | VariFuse Adjustable Infusion Catheter | QEY | Substantially Equivalent | |
| K253741 | V•Stick™ Vascular Access Set | DYB | Substantially Equivalent | |
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | DTK | Substantially Equivalent | |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) | DYB | Substantially Equivalent | |
| K233909 | Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister | QEW | Substantially Equivalent | |
| K232679 | Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister | QEW | Substantially Equivalent | |
| K233432 | 10F Sheath and Dilator Set | DYB | Substantially Equivalent | |
| K230669 | L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters | LJS | Substantially Equivalent | |
| K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | MMX | Substantially Equivalent | |
| K230631 | Kodiak™ Dual Port Coaxial Introducer Kit | DYB | Substantially Equivalent | |
| K223176 | Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister | KRA | Substantially Equivalent | |
| K213232 | NovaCore Semi-Automatic Biopsy Instrument | KNW | Substantially Equivalent | |
| K211798 | Cleaner Plus Thrombectomy System | QEW | Substantially Equivalent | |
| K213638 | Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) | DYB | Substantially Equivalent | |
| K213002 | SCORPION Portal Vein Access Set | DYB | Substantially Equivalent | |
| K202141 | Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set | DYB | Substantially Equivalent | |
| K200963 | Halo Single-Loop Microsnare Kit | MMX | Substantially Equivalent | |
| K201489 | Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set | DYB | Substantially Equivalent | |
| K200268 | Halo™ Single-Loop Snare Kit | MMX | Substantially Equivalent | |
| K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | MMX | Substantially Equivalent | |
| K160785 | Worker Guidewire | DQX | Substantially Equivalent | |
| K141969 | FIRSTSTIC N INTRODUCER | DYB | Substantially Equivalent | |
| K070384 | ARGON CONTINUOUS FLUSH DEVICE | KRA | Substantially Equivalent | |
| K052802 | MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE | KNW | Substantially Equivalent | |
| K011209 | MANAN SPRITACRE SPINAL NEEDLES | BSP | Substantially Equivalent | |
| K983620 | MANAN SPINAL NEEDLES | BSP | Substantially Equivalent | |
| K980536 | EPIDURAL NEEDLE | BSP | Substantially Equivalent | |
| K981386 | MANAN BLUNT NEEDLE | FPA | Substantially Equivalent | |
| K980211 | MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES | KNW | Substantially Equivalent | |
| K974446 | MANAN AUTOMATIC CUTTING NEEDLE | KNW | Substantially Equivalent | |
| K962977 | MRI COMPATIBLE BIOPSY NEEDLES | KNW | Substantially Equivalent | |
| K963767 | MANAN V.S. ACCESS NEEDLE/SET | FGE | Substantially Equivalent | |
| K961986 | MANAN D BAG | EXF | Substantially Equivalent | |
| K962001 | MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE | FMI | Substantially Equivalent | |
| K963849 | MANAN D BAG | EXF | Substantially Equivalent | |
| K963743 | MANAN PROSTATE UNI-LOCK | IWJ | Substantially Equivalent | |
| K961377 | MANAN PROSTATE LOCKING INTRODUCER SET | IWJ | Substantially Equivalent | |
| K961216 | MANAN INTRODUCER SHEALTH/NEEDLE | FGE | Substantially Equivalent | |
| K954147 | MANAN MALECOT BASKET DRAINAGE CATHETER | FEW | Substantially Equivalent | |
| K954132 | MANAN MANTA CATHETER FIXATION DISK | KNY | Substantially Equivalent | |
| K954043 | MANAN BILIARY DRAINAGE CATHETER | FGE | Substantially Equivalent | |
| K953713 | MANAN GENERAL UTILITY DRAINAGE CATHETER | LJE | Substantially Equivalent | |
| K953601 | MANAN UNIVERSAL SUMP DRAINAGE CATHETER | LJE | Substantially Equivalent | |
| K953547 | MANAN NEPHROSTOMY DRAINAGE CATHETER | LJE | Substantially Equivalent | |
| K943649 | GERTIE MARX NEEDLE | BSP | Substantially Equivalent | |
| K950732 | MANAN SUPER-CORE BIOPSY NEEDLE | KNW | Substantially Equivalent | |
| K943653 | MAMMOCORE BIOPSY TRAY | FRG | Unknown | |
| K943651 | TECHNA-CUT ASPIRATION NEEDLE | KNW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1625425 | 1625425 | ARGON MEDICAL DEVICES INC. | 1445 FLAT CREEK RD., ATHENS, TX 75751 US | 2026 | and 66 more, listed in full below |
| 1417485 | 1417485 | ARGON MEDICAL DEVICES, INC. | 241 W Palatine Rd, WHEELING, IL 60090 US | 2026 | and 24 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- KGZAccessories, Catheter
- KNYAccessories, Catheter, G-U
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CAZAnesthesia Conduction Kit
- EXFBag, Bile Collecting
- FNYBasin, Emesis
- FCGBiopsy Needle
- GESBlade, Scalpel
- DQRCannula, Catheter
- GEACannula, Surgical, General & Plastic Surgery
- KRACatheter, Continuous Flush
- GBQCatheter, Continuous Irrigation
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- FEWCatheter, Malecot
- GBOCatheter, Nephrostomy, General & Plastic Surgery
- DQYCatheter, Percutaneous
- HXDClamp
- GDJClamp, Surgical, General & Plastic Surgery
- DXCClamp, Vascular
- FMHContainer, Specimen, Sterile
- DWZDevice, Biopsy, Endomyocardial
- GCCDilator, Catheter
- KOEDilator, Urethral
- DREDilator, Vessel, For Percutaneous Catheterization
- KKXDrape, Surgical, Antimicrobial
- DTKFilter, Intravascular, Cardiovascular
- DOXFluorometer, Lead (Dedicated Instruments)
- GDYGauze/Sponge, Internal, X-Ray Detectable
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- DXTInjector And Syringe, Angiographic
- KNWInstrument, Biopsy
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- JDZMixer, Cement, For Clinical Use
- GAANeedle, Aspiration And Injection, Disposable
- GDMNeedle, Aspiration And Injection, Reusable
- DWONeedle, Biopsy, Cardiovascular
- GCBNeedle, Catheter
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FMINeedle, Hypodermic, Single Lumen
- KRBProbe, Thermodilution
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)
- FPASet, Administration, Intravascular
- FGEStents, Drains And Dilators For The Biliary Ducts
- FMGStopcock, I.V. Set
- FMFSyringe, Piston
- IWJSystem, Applicator, Radionuclide, Manual
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- IZISystem, X-Ray, Angiographic
- KGXTape And Bandage, Adhesive
- DRSTransducer, Blood-Pressure, Extravascular
- DRCTrocar
- KGCTube, Gastro-Enterostomy
- FPKTubing, Fluid Delivery
- DQXWire, Guide, Catheter
- FRGWrap, Sterilization
Recall records
Showing 25 of 145| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2804-2026 | L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 | Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection. | Class II | Open, Classified | |
| Z-2803-2026 | L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463 | Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection. | Class II | Open, Classified | |
| Z-2709-2026 | Bone Marrow Tray, REF: CB0033TL; CB0355TLA | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Class I | Open, Classified | |
| Z-2708-2026 | Arterial Line Kit 20ga x 6, REF: 400115A | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Class I | Open, Classified | |
| Z-2707-2026 | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Class I | Open, Classified | |
| Z-2706-2026 | General Biospy Tray, REF: GUTS1000 | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Class I | Open, Classified | |
| Z-2705-2026 | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Class I | Open, Classified | |
| Z-2704-2026 | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | Class I | Open, Classified | |
| Z-0589-2026 | Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated | Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied | Class II | Open, Classified | |
| Z-3192-2024 | BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 763114200X | Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis. | Class II | Open, Classified | |
| Z-2638-2024 | L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539 | Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay. | Class II | Open, Classified | |
| Z-2239-2023 | Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797 | There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism. | Class II | Open, Classified | |
| Z-0563-2022 | 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" | Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss. | Class II | Open, Classified | |
| Z-0354-2022 | SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; 701118090/SUPERCORE BIOPSY INSTR 18GA X 9CM; 701118150/SUPERCORE BIOPSY INSTR 18GA X 15CM; 701118200/SUPERCORE BIOPSY INSTR 18GA X 20CM; 701120090/SUPERCORE BIOPSY INSTR 20GA X 9CM; 701120150/SUPERCORE BIOPSY INSTR 20GA X 15CM; 701120200/SUPERCORE BIOPSY INSTR 20GA X 20CM; 701214090/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 9CM; 701214150/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 15CM; 701216090/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 9CM; 701216150/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 15CM; 701218090/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 9CM; 701218150/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 15CM; 701218200/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 20CM; 701220090/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 9CM; 701220150/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 15CM; 701220200/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 20CM; 701114090M/SUPERCORE BIOPSY INSTR 14GA X 9CM-MAMMOTOME; 701114150M/SUPERCORE BIOPSY INSTR 14GA X 15CM-MAMMOTOME; 701116090M/SUPERCORE BIOPSY INSTR 16GA X 9CM-MAMMOTOME; SC 1409/PGI Supercore 14GA x 9CM; SC 1609/PGI Supercore 16GA x 9CM; SC 1806/PGI Supercore 18GA x 6CM; | Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments. | Class II | Open, Classified | |
| Z-2501-2021 | Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma. | As a result of design changes, sheaths have exhibited cracking/breaking at the tips. | Class II | Open, Classified | |
| Z-1077-2021 | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO, | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function. | Class II | Terminated | |
| Z-1076-2021 | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO, | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function. | Class II | Terminated | |
| Z-1075-2021 | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO, | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function. | Class II | Terminated | |
| Z-1074-2021 | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO, | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function. | Class II | Terminated | |
| Z-1073-2021 | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO, | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function. | Class II | Terminated | |
| Z-1072-2021 | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO, | Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function. | Class II | Terminated | |
| Z-2806-2020 | ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. | Sterile introducer sheath set manufactured under one lot with different expiration dates. | Class II | Terminated | |
| Z-2109-2020 | Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures. | Tungsten coils of the guidewire included in the introducer kit were detaching. | Class II | Terminated | |
| Z-1938-2020 | PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Curved tip Introducer allows for contralateral access to the iliac artery and selected vasculature. Case Label: PAC Tray/5 Catheter Introducer Tray 8F, QTY 10/Bx, Rx Only, STERILE EO | Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead. | Class II | Terminated | |
| Z-1937-2020 | Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label: Arterial Line Kit/1 20ga x 3", Qty: 10/CS, CE 2797 | Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead. | Class II | Terminated |
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