Arrow Intl., Inc.
Everett, MA, US
Arrow Intl., Inc. appears in FDA device records in Everett, MA. FDA records list 111 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 111
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 111FDA records hold 111 510(k) clearances for Arrow Intl., Inc. between 1976 and 2010. The busiest year on record is 1996, with 11. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 4 |
| 1978 | 3 |
| 1979 | 1 |
| 1980 | 2 |
| 1981 | 4 |
| 1982 | 2 |
| 1984 | 3 |
| 1985 | 2 |
| 1986 | 2 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 8 |
| 1990 | 3 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 6 |
| 1994 | 2 |
| 1995 | 4 |
| 1996 | 11 |
| 1997 | 7 |
| 1998 | 5 |
| 1999 | 3 |
| 2000 | 6 |
| 2001 | 5 |
| 2002 | 4 |
| 2003 | 3 |
| 2004 | 6 |
| 2006 | 1 |
| 2007 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K100635 | ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 | LJS | Substantially Equivalent | |
| K093050 | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 | DQY | Substantially Equivalent | |
| K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | KKX | Substantially Equivalent | |
| K071998 | ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT | FMI | Substantially Equivalent | |
| K071111 | NON-ABSORBABLE SILK SUTURE | GAP | Substantially Equivalent | |
| K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES | DSP | Substantially Equivalent | |
| K042126 | PICC | LJS | Unknown | |
| K041153 | SHARPSAWAY II LOCKING DISPOSABLE CUP | FMI | Substantially Equivalent | |
| K040801 | INTRA-AORTIC BALLOON (IAB) | DSP | Substantially Equivalent | |
| K040802 | HEMOSONIC 200HEMODYNAMIC MONITOR | DPN | Substantially Equivalent | |
| K040260 | INTEGRAL HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | |
| K040100 | ARROW ECHOGENIC INTRODUCER NEEDLE | DQX | Substantially Equivalent | |
| K031153 | MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 | DPW | Substantially Equivalent | |
| K032962 | AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE | FOZ | Substantially Equivalent | |
| K022662 | DIATEK CANNON-CATHETER, MODEL CC5500 | MSD | Unknown | |
| K021723 | SHEATH ADAPTER, MODEL SA-09847 | DYB | Substantially Equivalent | |
| K021567 | STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 | CAZ | Substantially Equivalent | |
| K021462 | ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 | DSP | Substantially Equivalent | |
| K021120 | RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP | DQY | Substantially Equivalent | |
| K011761 | MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT | DYB | Substantially Equivalent | |
| K011056 | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD | QEW | Substantially Equivalent | |
| K002256 | ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP | DSP | Substantially Equivalent | |
| K002507 | TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT | DYB | Substantially Equivalent | |
| K010330 | ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U | DSP | Substantially Equivalent | |
| K003006 | TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION | LJT | Substantially Equivalent | |
| K993933 | 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO | MPB | Substantially Equivalent | |
| K001587 | 19 GA PLASTIC REINFORCED EPIDURAL CATHETER | CAZ | Substantially Equivalent | |
| K000729 | ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL | DSP | Substantially Equivalent | |
| K993691 | ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | |
| K993966 | 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER | DSP | Substantially Equivalent | |
| K991431 | 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT | MPB | Substantially Equivalent | |
| K984022 | PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT | MPB | Substantially Equivalent | |
| K990829 | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 | MCW | Substantially Equivalent | |
| K982141 | ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 | DXE | Substantially Equivalent | |
| K981782 | LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K970689 | IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U | DSP | Substantially Equivalent | |
| K970229 | ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET | DYB | Substantially Equivalent | |
| K965209 | ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) | DSP | Substantially Equivalent | |
| K970864 | ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS | FOZ | Substantially Equivalent | |
| K963865 | 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S | DSP | Substantially Equivalent | |
| K962577 | ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | |
| K970080 | ARROW-TREROTOLA PTD CATHETER | MCW | Substantially Equivalent | |
| K963920 | 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, | DSP | Substantially Equivalent | |
| K963257 | PERIPHERALLY INSERTED MEDLINE CATHETER | LJS | Substantially Equivalent | |
| K963104 | 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM | DSP | Substantially Equivalent | |
| K963684 | A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED) | LJT | Substantially Equivalent | |
| K960479 | ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER | LDF | Substantially Equivalent | |
| K961652 | LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017 | LJT | Substantially Equivalent | |
| K961615 | LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037 | LJT | Substantially Equivalent | |
| K961583 | A PORT DETACHED CATHETER SYSTEM CATALOG #1002 | LJT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KGZAccessories, Catheter
- CAZAnesthesia Conduction Kit
- JOLCatheter And Tip, Suction
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DXECatheter, Embolectomy
- DYGCatheter, Flow Directed
- MSDCatheter, Hemodialysis, Implanted
- MPBCatheter, Hemodialysis, Non-Implanted
- DQOCatheter, Intravascular, Diagnostic
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- GBXCatheter, Irrigation
- DQYCatheter, Percutaneous
- MCWCatheter, Peripheral, Atherectomy
- GBWCatheter, Peritoneal
- LFJCatheter, Subclavian
- KKXDrape, Surgical, Antimicrobial
- LDFElectrode, Pacemaker, Temporary
- DPWFlowmeter, Blood, Cardiovascular
- DXTInjector And Syringe, Angiographic
- DYBIntroducer, Catheter
- FMINeedle, Hypodermic, Single Lumen
- QEWPeripheral Mechanical Thrombectomy With Aspiration
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- JDCProsthesis, Elbow, Constrained, Cemented
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- FPASet, Administration, Intravascular
- FGEStents, Drains And Dilators For The Biliary Ducts
- GAPSuture, Nonabsorbable, Silk
- FMFSyringe, Piston
- DSPSystem, Balloon, Intra-Aortic And Control
- DPNThin Layer Chromatography, Propoxyphene
- DRCTrocar
- KNTTubes, Gastrointestinal (And Accessories)
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain