DXZ · Class II · 21 CFR 870.3470

FDA Product Code DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Leading manufacturers include W.L. Gore & Associates, Inc., Chase Medical, Inc. and Meadox Medicals, Div. Boston Scientific Corp..

90
Total
90
Cleared
137d
Avg days
1977
Since
90 devices
49–72 of 90
Cleared Aug 21, 1995
POLYETHYLENE TEREPHTHALATE (PET) PLEDGET
K953425
Davis & Geck, Inc.
Cardiovascular · 31d
Cleared Feb 22, 1995
CVPRO CARDIOVASCULAR PATCH
K943736
W.L. Gore & Associates, Inc.
Cardiovascular · 204d
Cleared Jul 07, 1994
VASCU-GUARD
K942010
Bio-Vascular, Inc.
Cardiovascular · 73d
Cleared May 18, 1994
GORE-TEX CARDIOVASCULAR PATCH
K940906
W.L. Gore & Associates, Inc.
Cardiovascular · 83d
Cleared Oct 22, 1993
GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE
K930950
W.L. Gore & Associates, Inc.
Cardiovascular · 241d
Cleared May 27, 1993
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
K931386
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 70d
Cleared Nov 04, 1992
TISSUE PATCH, TISSUE GRAFT
K921895
Bio-Vascular, Inc.
Cardiovascular · 196d
Cleared Dec 20, 1991
CARDIOVASCULAR REPAIR PATCH
K905073
Impra, Inc.
Cardiovascular · 406d
Cleared Nov 05, 1991
GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
K914448
W.L. Gore & Associates, Inc.
Cardiovascular · 32d
Cleared Nov 05, 1991
GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE
K914450
W.L. Gore & Associates, Inc.
Cardiovascular · 32d
Cleared Oct 11, 1991
GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM
K912107
W.L. Gore & Associates, Inc.
Cardiovascular · 151d
Cleared Mar 26, 1991
GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE
K910464
W.L. Gore & Associates, Inc.
Cardiovascular · 50d
Cleared Mar 11, 1991
WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS
K905496
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 94d
Cleared Nov 01, 1984
PERICARDIAL PATCH
K833763
American Edwards Laboratories
Cardiovascular · 372d
Cleared May 30, 1984
HANCOCK PERICARDIAL PATCH
K840262
Extracorporeal Medical Specialities, Inc.
Cardiovascular · 132d
Cleared Jan 06, 1984
GORE-TEX SURGICAL MEMBRANE
K831516
W.L. Gore & Associates, Inc.
Cardiovascular · 302d
Cleared Aug 31, 1983
HANCOCK PERICARDIAL PATCH
K830863
Extracorporeal Medical Specialities, Inc.
Cardiovascular · 166d
Cleared Aug 13, 1983
VASCULAR GRAFT/BIFURCATED/FEP-RINGED
K830806
W.L. Gore & Associates, Inc.
Cardiovascular · 152d
Cleared Mar 10, 1983
PATCH
K823345
Shiley, Inc.
Cardiovascular · 122d
Cleared Jan 12, 1983
GORE-TES EXPANDED PTFE PATCH
K821717
W.L. Gore & Associates, Inc.
Cardiovascular · 216d
Cleared Sep 16, 1981
GORE-TEX CARDIOVASCULAR PATCH
K811841
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Aug 31, 1981
DACRON PLEDGET SUTURE BUTTRESS
K812254
Ethicon, Inc.
Cardiovascular · 19d
Cleared Aug 12, 1981
TEFLON PLEDGET SUTURE BUTTRESS
K811872
Ethicon, Inc.
Cardiovascular · 42d
Cleared Aug 13, 1980
IONESCU-SHILEY PERICARDIAL PATCH
K801764
Shiley, Inc.
Cardiovascular · 16d