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Galt Medical Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K192195Sterile DilatorSeptember 26, 2019
K182660GaltTWSMay 30, 2019
K173287Elite HV RadialDecember 21, 2017
K172487Coaxial Dilator Set (Micro-Introducer)October 16, 2017
K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerJuly 5, 2016
K152528Attachable Cath Lab Hemostasis ValveDecember 2, 2015
K140028GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCERAugust 21, 2014
K123430MICROSLIDER TEARAWAY INTRODUCER SETApril 12, 2013
K112398TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORTApril 12, 2012
K071330GALTSTICK INTRODUCER SYSTEMOctober 31, 2007
K043525CATHETER INTRODUCERFebruary 9, 2005
K033542EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIREDecember 5, 2003
K031916GALT MEDICAL GUIDEWIREJuly 17, 2003
K021990GALT MEDICAL GUIDEWIREJuly 18, 2002
K982559GUIDEWIREFebruary 1, 1999