Medical Device Manufacturer · US , Garland , TX

Galt Medical Corp.

14 submissions · 12 cleared · Since 1999
14
Total
12
Cleared
0
Denied

Galt Medical Corp. — FDA 510(k) Submissions

Galt Medical Corp. has submitted 14 FDA 510(k) premarket notifications since 1999, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Introducer, Catheter, Wire, Guide, Catheter, Dilator, Vessel, For Percutaneous Catheterization, Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, Stylet, Catheter . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
Sterile Dilator
K192195 · DRE Dilator, Vessel, For... · Cardiovascular
Sep 2019 44d
GaltTWS
K182660 · DRB Stylet, Catheter · Cardiovascular
May 2019 247d
Elite HV Radial
K173287 · DYB Introducer, Catheter · Cardiovascular
Dec 2017 66d
Coaxial Dilator Set (Micro-Introducer)
K172487 · DRE Dilator, Vessel, For... · Cardiovascular
Oct 2017 60d
Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
K153533 · DYB Introducer, Catheter · Cardiovascular
Jul 2016 209d
Attachable Cath Lab Hemostasis Valve
K152528 · DTL Adaptor, Stopcock,... · Cardiovascular
Dec 2015 90d
GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
K140028 · DYB Introducer, Catheter · Cardiovascular
Aug 2014 227d
MICROSLIDER TEARAWAY INTRODUCER SET
K123430 · DYB Introducer, Catheter · Cardiovascular
Apr 2013 156d
GALTSTICK INTRODUCER SYSTEM
K071330 · DRE Dilator, Vessel, For... · Cardiovascular
Oct 2007 173d
CATHETER INTRODUCER
K043525 · DYB Introducer, Catheter · Cardiovascular
Feb 2005 50d
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE
K033542 · DQX Wire, Guide, Catheter · Cardiovascular
Dec 2003 25d
GALT MEDICAL GUIDEWIRE
K031916 · DQX Wire, Guide, Catheter · Cardiovascular
Jul 2003 27d
GALT MEDICAL GUIDEWIRE
K021990 · DQX Wire, Guide, Catheter · Cardiovascular
Jul 2002 30d
GUIDEWIRE
K982559 · DQX Wire, Guide, Catheter · Cardiovascular
Feb 1999 193d
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