Galt Medical Corp. - FDA 510(k) Cleared Devices

Cleared Sep 26, 2019

Sterile Dilator

K192195 · DRE

Cardiovascular · 44d

Cleared May 30, 2019

GaltTWS

K182660 · DRB

Cardiovascular · 247d

Cleared Dec 21, 2017

Elite HV Radial

K173287 · DYB

Cardiovascular · 66d

Cleared Oct 16, 2017

Coaxial Dilator Set (Micro-Introducer)

K172487 · DRE

Cardiovascular · 60d

Cleared Jul 05, 2016

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

K153533 · DYB

Cardiovascular · 209d

Cleared Dec 02, 2015

Attachable Cath Lab Hemostasis Valve

K152528 · DTL

Cardiovascular · 90d

Cleared Aug 21, 2014

GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER

K140028 · DYB

Cardiovascular · 227d

Cleared Apr 12, 2013

MICROSLIDER TEARAWAY INTRODUCER SET

K123430 · DYB

Cardiovascular · 156d

Cleared Oct 31, 2007

GALTSTICK INTRODUCER SYSTEM

K071330 · DRE

Cardiovascular · 173d

Cleared Feb 09, 2005

CATHETER INTRODUCER

K043525 · DYB

Cardiovascular · 50d

Cleared Dec 05, 2003

EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE

K033542 · DQX

Cardiovascular · 25d

Cleared Jul 17, 2003

GALT MEDICAL GUIDEWIRE

K031916 · DQX

Cardiovascular · 27d