FDA 510(k) Applications for Medical Device Product Code "DXZ"
(Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)

FDA 510(k) Number Applicant Device Name Decision Date
K162579 Admedus Regen Pty Ltd VascuCel 10/14/2016
K151865 AESCULAP, INC. PremiPatch PTFE Pledget 10/27/2015
K833763 AMERICAN EDWARDS LABORATORIES PERICARDIAL PATCH 11/01/1984
K060396 ATRIUM MEDICAL CORP. IVENA VASCULAR PATCH 05/12/2006
K992776 ATRIUM MEDICAL CORP. UNI-GRAFT K DV PATCH 11/16/1999
K971726 BIO-VASCULAR, INC. CV PERI-GUARD - CARDIOVASCULAR PATCH 04/10/1998
K983602 BIO-VASCULAR, INC. CV PERI-GUARD AND VASCU-GUARD 11/12/1998
K921895 BIO-VASCULAR, INC. TISSUE PATCH, TISSUE GRAFT 11/04/1992
K942010 BIO-VASCULAR, INC. VASCU-GUARD 07/07/1994
K041716 BOSTON SCIENTIFIC CORP. PTFE FELTS AND PLEDGETS 07/22/2004
K994032 BRIDGER BIOMED, INC. FLUORO-TEX CARDIOVASCULAR PATCH 07/07/2000
K973178 BRIDGER BIOMED, INC. FLUORO-TEX SURGICAL MEMBRANE 11/24/1997
K130872 CELXCEL PTY LTD CARDIOCEL 01/30/2014
K021129 CHASE MEDICAL, INC. CHARE CARIOVASCULAR PATCH 06/03/2002
K012248 CHASE MEDICAL, INC. CHASE CARDIOVASCULAR PATCH 08/10/2001
K001662 CHASE MEDICAL, INC. CHASE CARDIOVASCULAR PATCH 08/02/2000
K003467 CHASE MEDICAL, INC. CHASE CARDIOVASCULAR PATCH 01/29/2001
K020132 CHASE MEDICAL, INC. CHASE CARDIOVASCULAR PATCH KIT 02/26/2002
K020233 CHASE MEDICAL, INC. CHASE CARDIOVASCULAR PATCH KIT 03/14/2002
K022093 CHASE MEDICAL, INC. CHASE CARDIOVASCULAR PATCH KIT 09/20/2002
K001785 COOK BIOTECH, INC. SURGISIS PERIPHERAL VASCULAR PATCH 12/27/2000
K140789 CORMATRIX CARDIOVASCULAR, INC. CORMATRIX ECM FOR VASCULAR REPAIR 07/15/2014
K063349 CORMATRIX CARDIOVASCULAR, INC. CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR 02/16/2007
K152127 CORMATRIX CARDIOVASCULAR, INC. CorMatrix Tyke 02/04/2016
K111187 CORMATRIX CARDIOVASCULAR, INC. PATCH, PLEDGET AND INTRACARDIAC 07/26/2011
K051405 CORMATRIX CARDIOVASCULAR, INC. REGENSIS PERICARDIAL PATCH 08/31/2005
K091626 CRYOLIFE, INC. CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH 08/07/2009
K101866 CRYOLIFE, INC. CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH 07/23/2010
K162506 CryoLife, Inc. PhotoFix Decellularized Bovine Pericardium 03/09/2017
K953425 DAVIS & GECK, INC. POLYETHYLENE TEREPHTHALATE (PET) PLEDGET 08/21/1995
K953289 DAVIS & GECK, INC. TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET 08/21/1995
K082139 EDWARDS LIFESCIENCES, LLC. EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 10/23/2008
K812254 ETHICON, INC. DACRON PLEDGET SUTURE BUTTRESS 08/31/1981
K003070 ETHICON, INC. ETHIBOND EXCEL VALVE LOOP SUTURE 11/07/2000
K811872 ETHICON, INC. TEFLON PLEDGET SUTURE BUTTRESS 08/12/1981
K830863 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. HANCOCK PERICARDIAL PATCH 08/31/1983
K840262 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. HANCOCK PERICARDIAL PATCH 05/30/1984
K833021 GENETIC PERI-GUARD PERICARDIAL PATCH-HERNIA 12/26/1983
K842066 GENETIC LABORATORIES, INC. PERI-GUARD PERICARDIAL PATCH 12/30/1985
K821532 GENETIC LABORATORIES, INC. PERIGUARD PERICARDIAL PATCH 08/19/1982
K963967 GLYCAR, INC. GLYCAR PERICARDIAL PATCH 10/31/1997
K963368 GLYCAR, INC. GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE 10/31/1997
K052416 HANCOCK/JAFFE LABORATORIES PERIPRO PATCH 10/25/2005
K905073 IMPRA, INC. CARDIOVASCULAR REPAIR PATCH 12/20/1991
K881508 INTERVASCULAR, INC. OCHSNER & MICRON FABRIC PATCH 05/25/1988
K921659 INTERVASCULAR, INC. ULTRA LOW POROSITY DACRON WOVEN PATCH 11/25/1992
K101740 LEMAITRE VASCULAR, INC. ALBOSURE POLYESTER VASCULAR PATCH 09/20/2010
K081438 LifeNet Health MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT 10/17/2008
K090637 MAST BIOSURGERY USA INC. CARDIO-WRAP 01/07/2010
K760516 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. FELT, SURGICAL DACRON 01/05/1977
K962342 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH 09/10/1996
K955349 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC 02/14/1996
K931386 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC 05/27/1993
K905496 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS 03/11/1991
K041736 PERITEC BIOSCIENCES, LLC. PFA PATCH 01/13/2005
K031948 PM DEVICES, INC. PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 09/16/2003
K791792 SCIMED LIFE SYSTEMS, INC. "SCI MED PERICARDIAL SUBSTITUTE" 12/07/1979
K974914 SHELHIGH, INC. SHELHIGH NO-REACT PERICARDIAL PATCHES 06/03/1998
K982810 SHELHIGH, INC. SHELHIGH NO-REACT VASCUPATCH 10/28/1998
K964467 SHELHIGH, INC. SHELHIGH PERICARDIAL PATCH 09/23/1997
K801764 SHILEY, INC. IONESCU-SHILEY PERICARDIAL PATCH 08/13/1980
K823345 SHILEY, INC. PATCH 03/10/1983
K112683 SOLIMAS MEDICAL, INC. SMI CARDIOVASCULAR PACH 12/14/2011
K122105 SOLINAS MEDICAL INC SMI CARDIOVASCULAR PATCH 12/07/2012
K031586 SOMANETICS CORP. CORRESTORE PATCH SYSTEM 08/07/2003
K040162 SOMANETICS CORP. CORRESTORE PATCH SYSTEM 03/16/2004
K011487 SOMANETICS CORP. CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS 11/21/2001
K972201 SULZER CARBOMEDICS, INC. PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE 04/14/1998
K993288 SULZER CARBOMEDICS, INC. SULZER CARBOMEDICS CARDIOFIX PERICARDIUM 12/29/1999
K142461 Synovis Life Technologies Inc. VASCU-GUARD Peripheral Vascular Patch 11/25/2014
K142447 Synovis Life Technologies. Inc. PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch 01/07/2015
K040415 SYNOVIS SURGICAL INNOVATIONS PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT 04/14/2004
K122306 SYNOVIS SURGICAL INNOVATIONS SYNOVIS COLLAGEN MATRIX (TBD) 03/08/2013
K770835 USCI, DIV. C.R. BARD, INC. PATCH FABRIC 10/05/1977
K963611 VASCUTEK LTD. VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH 11/21/1996
K984526 W.L. GORE & ASSOCIATES,INC ACUSEAL CARDIOVASCULAR PATCH 04/08/1999
K943736 W.L. GORE & ASSOCIATES,INC CVPRO CARDIOVASCULAR PATCH 02/22/1995
K821717 W.L. GORE & ASSOCIATES,INC GORE-TES EXPANDED PTFE PATCH 01/12/1983
K811841 W.L. GORE & ASSOCIATES,INC GORE-TEX CARDIOVASCULAR PATCH 09/16/1981
K940906 W.L. GORE & ASSOCIATES,INC GORE-TEX CARDIOVASCULAR PATCH 05/18/1994
K930950 W.L. GORE & ASSOCIATES,INC GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE 10/22/1993
K912107 W.L. GORE & ASSOCIATES,INC GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM 10/11/1991
K831516 W.L. GORE & ASSOCIATES,INC GORE-TEX SURGICAL MEMBRANE 01/06/1984
K914448 W.L. GORE & ASSOCIATES,INC GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE 11/05/1991
K910464 W.L. GORE & ASSOCIATES,INC GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE 03/26/1991
K914450 W.L. GORE & ASSOCIATES,INC GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE 11/05/1991
K012098 W.L. GORE & ASSOCIATES,INC PRECLUDE PERICARDIAL MEMBRANE 09/20/2001
K830806 W.L. GORE & ASSOCIATES,INC VASCULAR GRAFT/BIFURCATED/FEP-RINGED 08/13/1983


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