# Galt Medical Corp.

- Location (FDA's records): Garland, TX
- FDA decisions: 15 (1999–2019): 15 510(k) clearances
- Names in FDA's records: Galt Medical Corp. (14); Galt Medical (1)
- Product codes: DYB (6), DQX (4), DRE (3), DRB (1), DTL (1)
- 510(k) review time since 2016: median 63 days, against 83 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 28 (17 its own); citations of its devices by later devices: 26 (17 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Xentek Medical, Inc.: 6 (https://510kreport.com/company/xentek-medical)
- Acme-Monaco Corp.: 1 (https://510kreport.com/company/acme-monaco)
- Togo Medikit Co., Ltd.: 1 (https://510kreport.com/company/togo-medikit)
- Tfx Medical Group: 1 (https://510kreport.com/company/tfx-medical-group)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)

## Firms that cite its devices most
- Vascular Solutions, Inc.: 2 (https://510kreport.com/company/vascular-solutions)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Toray Industries (America), Inc.: 1 (https://510kreport.com/company/toray-industries-america)
- VascuTech Medical, LLC: 1 (https://510kreport.com/company/vascutech-medical)
- Arrow International, LLC (A subsidiary of Teleflex, Inc.): 1 (https://510kreport.com/company/arrow-international-a-subsidiary-of-teleflex)
- AngioDynamics, Inc.: 1 (https://510kreport.com/company/angiodynamics)
- Acutus Medical, Inc.: 1 (https://510kreport.com/company/acutus-medical)
- Health Line International Corporation: 1 (https://510kreport.com/company/health-line-international)

## Its most-cited devices
- K043525: Catheter Introducer (2005), cited by 5
- K982559: Guidewire (1999), cited by 5
- K153533: Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (2016), cited by 3
- K021990: Galt Medical Guidewire (2002), cited by 3
- K112398: Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side Port (2012), cited by 3
- K152528: Attachable Cath Lab Hemostasis Valve (2015), cited by 2

## Recent decisions
- K192195: Sterile Dilator (Sep 26, 2019)
- K182660: GaltTWS (May 30, 2019)
- K173287: Elite HV Radial (Dec 21, 2017)
- K172487: Coaxial Dilator Set (Micro-Introducer) (Oct 16, 2017)
- K153533: Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (Jul 5, 2016)
- K152528: Attachable Cath Lab Hemostasis Valve (Dec 2, 2015)
- K140028: Galt Vti Low Insertion Valve Tearaway Introducer (Aug 21, 2014)
- K123430: Microslider Tearaway Introducer Set (Apr 12, 2013)

Source page: https://510kreport.com/company/galt-medical