Galt Medical Corp
Garland, TX, US
GALT MEDICAL CORP. appears in FDA device records in Garland, TX. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 22 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Galt Medical Corp between 1999 and 2019. The busiest year on record is 2003, with 2. The most recent is 2019, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2002 | 1 |
| 2003 | 2 |
| 2005 | 1 |
| 2007 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2019 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192195 | Sterile Dilator | DRE | Substantially Equivalent | |
| K182660 | GaltTWS | DRB | Substantially Equivalent | |
| K173287 | Elite HV Radial | DYB | Unknown | |
| K172487 | Coaxial Dilator Set (Micro-Introducer) | DRE | Unknown | |
| K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | DYB | Substantially Equivalent | |
| K152528 | Attachable Cath Lab Hemostasis Valve | DTL | Substantially Equivalent | |
| K140028 | GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER | DYB | Substantially Equivalent | |
| K123430 | MICROSLIDER TEARAWAY INTRODUCER SET | DYB | Substantially Equivalent | |
| K112398 | TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT | DYB | Substantially Equivalent | |
| K071330 | GALTSTICK INTRODUCER SYSTEM | DRE | Substantially Equivalent | |
| K043525 | CATHETER INTRODUCER | DYB | Substantially Equivalent | |
| K033542 | EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE | DQX | Substantially Equivalent | |
| K031916 | GALT MEDICAL GUIDEWIRE | DQX | Substantially Equivalent | |
| K021990 | GALT MEDICAL GUIDEWIRE | DQX | Substantially Equivalent | |
| K982559 | GUIDEWIRE | DQX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1649395 | 3000718472 | GALT MEDICAL CORP. | 2220 Merritt Dr, GARLAND, TX 75041 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- GESBlade, Scalpel
- DREDilator, Vessel, For Percutaneous Catheterization
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- GCBNeedle, Catheter
- OFLPercutaneous Sheath Introducer Kit
- DRBStylet, Catheter
- KYZSyringe, Irrigating (Non Dental)
- GAXTourniquet, Nonpneumatic
- DQXWire, Guide, Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2917-2026 | Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. | Class II | Open, Classified | |
| Z-1737-2025 | Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages. | Due to a potential open seal in the sterile barrier packaging. | Class II | Open, Classified | |
| Z-1736-2025 | Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires | Due to a potential open seal in the sterile barrier packaging. | Class II | Open, Classified | |
| Z-1735-2025 | Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick. | Due to a potential open seal in the sterile barrier packaging. | Class II | Open, Classified | |
| Z-1734-2025 | GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature. | Due to a potential open seal in the sterile barrier packaging. | Class II | Open, Classified | |
| Z-1733-2025 | B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature. | Due to a potential open seal in the sterile barrier packaging . | Class II | Open, Classified | |
| Z-1732-2025 | B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick. | Due to a potential open seal in the sterile barrier packaging . | Class II | Open, Classified | |
| Z-1731-2025 | GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups. | Due to a potential open seal in the sterile barrier packaging . | Class II | Open, Classified | |
| Z-1969-2023 | Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk) | Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device. | Class II | Open, Classified | |
| Z-1968-2023 | Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 | Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device. | Class II | Open, Classified | |
| Z-0568-2021 | Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16 | Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle. | Class II | Terminated | |
| Z-2565-2018 | Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46 | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient. | Class II | Terminated | |
| Z-2564-2018 | TVS LPA, Catalog #: DIL-059-00 | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient. | Class II | Terminated | |
| Z-2563-2018 | Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15, | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient. | Class II | Terminated | |
| Z-2562-2018 | Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055 | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient. | Class II | Terminated | |
| Z-2561-2018 | 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03 | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient. | Class II | Terminated | |
| Z-2560-2018 | 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08, | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient. | Class II | Terminated | |
| Z-2559-2018 | 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14; 5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04; 6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11; 7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12; 8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02; 9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88 10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15; | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient. | Class II | Terminated | |
| Z-2558-2018 | 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07 4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16; | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient. | Class II | Terminated | |
| Z-2589-2014 | GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature. | The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient. | Class II | Terminated | |
| Z-2588-2014 | GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature. | The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient. | Class II | Terminated | |
| Z-1592-2010 | Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369. | Potential problem with pouch seal thus affecting sterile product. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain