Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
FDA product code DXZ · 85 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.3470
- Review panel
- CV
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1977-01-05 – 2025-04-18
DXZ
2025-04-18
DXZ
2020-07-08
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
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DXZ
2017-03-09
PhotoFix Decellularized Bovine Pericardium
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DXZ
2016-10-14
VascuCel
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DXZ
2016-02-04
CorMatrix Tyke
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DXZ
2013-03-08
SYNOVIS COLLAGEN MATRIX (TBD)
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DXZ
2012-12-07
SMI CARDIOVASCULAR PATCH
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DXZ
2011-12-14
SMI CARDIOVASCULAR PACH
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DXZ
2011-07-26
PATCH, PLEDGET AND INTRACARDIAC
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DXZ
2010-09-20
ALBOSURE POLYESTER VASCULAR PATCH
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DXZ
2010-07-23
CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
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DXZ
2010-01-07
CARDIO-WRAP
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DXZ
2009-08-07
CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH
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DXZ
2008-10-23
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
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DXZ
2008-10-17
MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
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DXZ
2007-02-16
CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
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DXZ
2006-05-12
IVENA VASCULAR PATCH
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DXZ
2005-10-25
PERIPRO PATCH
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DXZ
2005-08-31
REGENSIS PERICARDIAL PATCH
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DXZ
2005-01-13
PFA PATCH
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DXZ
2004-07-22
PTFE FELTS AND PLEDGETS
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DXZ
2004-04-14
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
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DXZ
2004-03-16
CORRESTORE PATCH SYSTEM
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DXZ
2003-09-16
PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
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DXZ
2003-08-07
CORRESTORE PATCH SYSTEM
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DXZ
2002-09-20
CHASE CARDIOVASCULAR PATCH KIT
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DXZ
2002-06-03
CHARE CARIOVASCULAR PATCH
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DXZ
2002-03-14
CHASE CARDIOVASCULAR PATCH KIT
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DXZ
2002-02-26
CHASE CARDIOVASCULAR PATCH KIT
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DXZ
2001-11-21
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS
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DXZ
2001-09-20
PRECLUDE PERICARDIAL MEMBRANE
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DXZ
2001-08-10
CHASE CARDIOVASCULAR PATCH
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DXZ
2001-01-29
CHASE CARDIOVASCULAR PATCH
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DXZ
2000-12-27
SURGISIS PERIPHERAL VASCULAR PATCH
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DXZ
2000-11-07
ETHIBOND EXCEL VALVE LOOP SUTURE
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DXZ
2000-08-02
CHASE CARDIOVASCULAR PATCH
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DXZ
2000-07-07
FLUORO-TEX CARDIOVASCULAR PATCH
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DXZ
1999-12-29
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
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DXZ
1999-11-16
UNI-GRAFT K DV PATCH
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DXZ
1999-04-08
ACUSEAL CARDIOVASCULAR PATCH
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DXZ
1998-11-12
CV PERI-GUARD AND VASCU-GUARD
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DXZ
1998-10-28
SHELHIGH NO-REACT VASCUPATCH
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DXZ
1998-06-03
SHELHIGH NO-REACT PERICARDIAL PATCHES
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DXZ
1998-04-14
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
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DXZ
1998-04-10
CV PERI-GUARD - CARDIOVASCULAR PATCH
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DXZ
1997-11-24
FLUORO-TEX SURGICAL MEMBRANE
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DXZ
1997-10-31
GLYCAR PERICARDIAL PATCH
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DXZ
1997-10-31
GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE
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DXZ
1997-09-23
SHELHIGH PERICARDIAL PATCH
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DXZ
1996-11-21
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH
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DXZ
1996-09-10
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
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DXZ
1996-02-14
HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
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DXZ
1995-08-21
POLYETHYLENE TEREPHTHALATE (PET) PLEDGET
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DXZ
1995-08-21
TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET
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DXZ
1995-02-22
CVPRO CARDIOVASCULAR PATCH
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DXZ
1994-07-07
VASCU-GUARD
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DXZ
1994-05-18
GORE-TEX CARDIOVASCULAR PATCH
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DXZ
1993-10-22
GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE
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DXZ
1993-05-27
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
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DXZ
1992-11-25
ULTRA LOW POROSITY DACRON WOVEN PATCH
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DXZ
1992-11-04
TISSUE PATCH, TISSUE GRAFT
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DXZ
1991-12-20
CARDIOVASCULAR REPAIR PATCH
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DXZ
1991-11-05
GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE
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DXZ
1991-11-05
GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
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DXZ
1991-10-11
GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM
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DXZ
1991-03-26
GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE
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DXZ
1991-03-11
WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS
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DXZ
1988-05-25
OCHSNER & MICRON FABRIC PATCH
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DXZ
1985-12-30
PERI-GUARD PERICARDIAL PATCH
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DXZ
1984-11-01
PERICARDIAL PATCH
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DXZ
1984-05-30
HANCOCK PERICARDIAL PATCH
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DXZ
1984-01-06
GORE-TEX SURGICAL MEMBRANE
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DXZ
1983-12-26
PERI-GUARD PERICARDIAL PATCH-HERNIA
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DXZ
1983-08-31
HANCOCK PERICARDIAL PATCH
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DXZ
1983-08-13
VASCULAR GRAFT/BIFURCATED/FEP-RINGED
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DXZ
1983-03-10
PATCH
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DXZ
1983-01-12
GORE-TES EXPANDED PTFE PATCH
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DXZ
1982-08-19
PERIGUARD PERICARDIAL PATCH
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DXZ
1981-09-16
GORE-TEX CARDIOVASCULAR PATCH
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DXZ
1981-08-31
DACRON PLEDGET SUTURE BUTTRESS
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DXZ
1981-08-12
TEFLON PLEDGET SUTURE BUTTRESS
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DXZ
1980-08-13
IONESCU-SHILEY PERICARDIAL PATCH
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DXZ
1979-12-07
SCI MED PERICARDIAL SUBSTITUTE
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DXZ
1977-10-05
PATCH FABRIC
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DXZ
1977-01-05
FELT, SURGICAL DACRON
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