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
25–48 of 90
Cleared Feb 26, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020132
Chase Medical, Inc.
Cardiovascular · 42d
Cleared Sep 20, 2001
PRECLUDE PERICARDIAL MEMBRANE
K012098
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Aug 10, 2001
CHASE CARDIOVASCULAR PATCH
K012248
Chase Medical, Inc.
Cardiovascular · 24d
Cleared Jan 29, 2001
CHASE CARDIOVASCULAR PATCH
K003467
Chase Medical, Inc.
Cardiovascular · 82d
Cleared Dec 27, 2000
SURGISIS PERIPHERAL VASCULAR PATCH
K001785
Cook Biotech, Inc.
Cardiovascular · 197d
Cleared Nov 07, 2000
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070
Ethicon, Inc.
Cardiovascular · 36d
Cleared Aug 02, 2000
CHASE CARDIOVASCULAR PATCH
K001662
Chase Medical, Inc.
Cardiovascular · 63d
Cleared Jul 07, 2000
FLUORO-TEX CARDIOVASCULAR PATCH
K994032
Bridger Biomed, Inc.
Cardiovascular · 224d
Cleared Dec 29, 1999
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
K993288
Sulzer Carbomedics, Inc.
Cardiovascular · 89d
Cleared Nov 16, 1999
UNI-GRAFT K DV PATCH
K992776
Atrium Medical Corp.
Cardiovascular · 90d
Cleared Apr 08, 1999
ACUSEAL CARDIOVASCULAR PATCH
K984526
W.L. Gore & Associates, Inc.
Cardiovascular · 108d
Cleared Nov 12, 1998
CV PERI-GUARD AND VASCU-GUARD
K983602
Bio-Vascular, Inc.
Cardiovascular · 30d
Cleared Oct 28, 1998
SHELHIGH NO-REACT VASCUPATCH
K982810
Shelhigh, Inc.
Cardiovascular · 78d
Cleared Jun 03, 1998
SHELHIGH NO-REACT PERICARDIAL PATCHES
K974914
Shelhigh, Inc.
Cardiovascular · 177d
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