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 Cormatrix Cardiovascular, Inc..

90
Total
90
Cleared
137d
Avg days
1977
Since
90 devices
49–72 of 90
Cleared Apr 14, 1998
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
K972201
Sulzer Carbomedics, Inc.
Cardiovascular · 307d
Cleared Apr 10, 1998
CV PERI-GUARD - CARDIOVASCULAR PATCH
K971726
Bio-Vascular, Inc.
Cardiovascular · 336d
Cleared Nov 24, 1997
FLUORO-TEX SURGICAL MEMBRANE
K973178
Bridger Biomed, Inc.
Cardiovascular · 91d
Cleared Oct 31, 1997
GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS
K963368
Glycar, Inc.
Cardiovascular · 430d
Cleared Oct 31, 1997
GLYCAR PERICARDIAL PATCH
K963967
Glycar, Inc.
Cardiovascular · 394d
Cleared Sep 23, 1997
SHELHIGH PERICARDIAL PATCH
K964467
Shelhigh, Inc.
Cardiovascular · 320d
Cleared Nov 21, 1996
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH
K963611
Vascutek, Ltd.
Cardiovascular · 72d
Cleared Sep 10, 1996
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
K962342
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 84d
Cleared Feb 14, 1996
HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
K955349
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 85d
Cleared Aug 21, 1995
TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET
K953289
Davis & Geck, Inc.
Cardiovascular · 38d
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 25, 1992
ULTRA LOW POROSITY DACRON WOVEN PATCH
K921659
Intervascular, Inc.
Cardiovascular · 232d
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