Atlas FDA

DXZ

90 FDA 510(k) clearances · Product code

90 daysmedian time to decision
307 days90th percentile
90clearances measured

FDA profile

Official device name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3470
Medical specialty
Cardiovascular
Flags
Implant
Adverse events (MAUDE)
2021: 80 · 2022: 77 · 2023: 40 · 2024: 49 · 2025: 122 · 2026: 37
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PeriBeam® Pericardial Membrane (K240775)Tamabio2025-04-18
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (K200955)Vascutek, Ltd.2020-07-08
PhotoFix Decellularized Bovine Pericardium (K162506)Cryolife, Inc.2017-03-09
VascuCel (K162579)Admedus Regen Pty, Ltd.2016-10-14
CorMatrix Tyke (K152127)Cormatrix Cardiovascular, Inc.2016-02-04
PremiPatch PTFE Pledget (K151865)Aesculap, Inc.2015-10-27
PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (K142447)Synovis Life Technologies, Inc.2015-01-07
VASCU-GUARD Peripheral Vascular Patch (K142461)Synovis Life Technologies, Inc.2014-11-25
CORMATRIX ECM FOR VASCULAR REPAIR (K140789)Cormatrix Cardiovascular, Inc.2014-07-15
CARDIOCEL (K130872)Celxcel Pty, Ltd.2014-01-30
SYNOVIS COLLAGEN MATRIX (TBD) (K122306)Synovis Surgical Innovations2013-03-08
SMI CARDIOVASCULAR PATCH (K122105)Solinas Medical, Inc.2012-12-07
SMI CARDIOVASCULAR PACH (K112683)Solimas Medical, Inc.2011-12-14
PATCH, PLEDGET AND INTRACARDIAC (K111187)Cormatrix Cardiovascular, Inc.2011-07-26
ALBOSURE POLYESTER VASCULAR PATCH (K101740)LeMaitre Vascular, Inc.2010-09-20
CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH (K101866)Cryolife, Inc.2010-07-23
CARDIO-WRAP (K090637)Mast Biosurgery USA, Inc.2010-01-07
CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH (K091626)Cryolife, Inc.2009-08-07
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 (K082139)Edwards Lifesciences, LLC2008-10-23
MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT (K081438)Lifenet Health2008-10-17
CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR (K063349)Cormatrix Cardiovascular, Inc.2007-02-16
IVENA VASCULAR PATCH (K060396)Atrium Medical Corp.2006-05-12
PERIPRO PATCH (K052416)Hancock/Jaffe Laboratories2005-10-25
REGENSIS PERICARDIAL PATCH (K051405)Cormatrix Cardiovascular, Inc.2005-08-31
PFA PATCH (K041736)Peritec Biosciences, LLC2005-01-13
PTFE FELTS AND PLEDGETS (K041716)Boston Scientific Corp2004-07-22
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT (K040415)Synovis Surgical Innovations2004-04-14
CORRESTORE PATCH SYSTEM (K040162)Somanetics Corp.2004-03-16
PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 (K031948)Pm Devices, Inc.2003-09-16
CORRESTORE PATCH SYSTEM (K031586)Somanetics Corp.2003-08-07
CHASE CARDIOVASCULAR PATCH KIT (K022093)Chase Medical, Inc.2002-09-20
CHARE CARIOVASCULAR PATCH (K021129)Chase Medical, Inc.2002-06-03
CHASE CARDIOVASCULAR PATCH KIT (K020233)Chase Medical, Inc.2002-03-14
CHASE CARDIOVASCULAR PATCH KIT (K020132)Chase Medical, Inc.2002-02-26
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS (K011487)Somanetics Corp.2001-11-21
PRECLUDE PERICARDIAL MEMBRANE (K012098)W. L. Gore & Associates, Inc.2001-09-20
CHASE CARDIOVASCULAR PATCH (K012248)Chase Medical, Inc.2001-08-10
CHASE CARDIOVASCULAR PATCH (K003467)Chase Medical, Inc.2001-01-29
SURGISIS PERIPHERAL VASCULAR PATCH (K001785)Cook Biotech, Inc.2000-12-27
ETHIBOND EXCEL VALVE LOOP SUTURE (K003070)ETHICON, Inc.2000-11-07
CHASE CARDIOVASCULAR PATCH (K001662)Chase Medical, Inc.2000-08-02
FLUORO-TEX CARDIOVASCULAR PATCH (K994032)Bridger Biomed, Inc.2000-07-07
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM (K993288)Sulzer Carbomedics, Inc.1999-12-29
UNI-GRAFT K DV PATCH (K992776)Atrium Medical Corp.1999-11-16
ACUSEAL CARDIOVASCULAR PATCH (K984526)W. L. Gore & Associates, Inc.1999-04-08
CV PERI-GUARD AND VASCU-GUARD (K983602)Bio-Vascular, Inc.1998-11-12
SHELHIGH NO-REACT VASCUPATCH (K982810)Shelhigh, Inc.1998-10-28
SHELHIGH NO-REACT PERICARDIAL PATCHES (K974914)Shelhigh, Inc.1998-06-03
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE (K972201)Sulzer Carbomedics, Inc.1998-04-14
CV PERI-GUARD - CARDIOVASCULAR PATCH (K971726)Bio-Vascular, Inc.1998-04-10
FLUORO-TEX SURGICAL MEMBRANE (K973178)Bridger Biomed, Inc.1997-11-24
GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE (K963368)Glycar, Inc.1997-10-31
GLYCAR PERICARDIAL PATCH (K963967)Glycar, Inc.1997-10-31
SHELHIGH PERICARDIAL PATCH (K964467)Shelhigh, Inc.1997-09-23
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH (K963611)Vascutek, Ltd.1996-11-21
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH (K962342)Meadox Medicals, Div. Boston Scientific Corp.1996-09-10
HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC (K955349)Meadox Medicals, Div. Boston Scientific Corp.1996-02-14
TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET (K953289)Davis & Geck, Inc.1995-08-21
POLYETHYLENE TEREPHTHALATE (PET) PLEDGET (K953425)Davis & Geck, Inc.1995-08-21
CVPRO CARDIOVASCULAR PATCH (K943736)W. L. Gore & Associates, Inc.1995-02-22
VASCU-GUARD (K942010)Bio-Vascular, Inc.1994-07-07
GORE-TEX CARDIOVASCULAR PATCH (K940906)W. L. Gore & Associates, Inc.1994-05-18
GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE (K930950)W. L. Gore & Associates, Inc.1993-10-22
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC (K931386)Meadox Medicals, Div. Boston Scientific Corp.1993-05-27
ULTRA LOW POROSITY DACRON WOVEN PATCH (K921659)Intervascular, Inc.1992-11-25
TISSUE PATCH, TISSUE GRAFT (K921895)Bio-Vascular, Inc.1992-11-04
CARDIOVASCULAR REPAIR PATCH (K905073)Impra, Inc.1991-12-20
GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE (K914448)W. L. Gore & Associates, Inc.1991-11-05
GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE (K914450)W. L. Gore & Associates, Inc.1991-11-05
GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM (K912107)W. L. Gore & Associates, Inc.1991-10-11
GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE (K910464)W. L. Gore & Associates, Inc.1991-03-26
WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS (K905496)Meadox Medicals, Div. Boston Scientific Corp.1991-03-11
OCHSNER & MICRON FABRIC PATCH (K881508)Intervascular, Inc.1988-05-25
PERI-GUARD PERICARDIAL PATCH (K842066)Genetic Laboratories, Inc.1985-12-30
PERICARDIAL PATCH (K833763)American Edwards Laboratories1984-11-01
HANCOCK PERICARDIAL PATCH (K840262)Extracorporeal Medical Specialities, Inc.1984-05-30
GORE-TEX SURGICAL MEMBRANE (K831516)W. L. Gore & Associates, Inc.1984-01-06
PERI-GUARD PERICARDIAL PATCH-HERNIA (K833021)Genetic1983-12-26
HANCOCK PERICARDIAL PATCH (K830863)Extracorporeal Medical Specialities, Inc.1983-08-31
VASCULAR GRAFT/BIFURCATED/FEP-RINGED (K830806)W. L. Gore & Associates, Inc.1983-08-13
PATCH (K823345)Shiley, Inc.1983-03-10
GORE-TES EXPANDED PTFE PATCH (K821717)W. L. Gore & Associates, Inc.1983-01-12
PERIGUARD PERICARDIAL PATCH (K821532)Genetic Laboratories, Inc.1982-08-19
GORE-TEX CARDIOVASCULAR PATCH (K811841)W. L. Gore & Associates, Inc.1981-09-16
DACRON PLEDGET SUTURE BUTTRESS (K812254)ETHICON, Inc.1981-08-31
TEFLON PLEDGET SUTURE BUTTRESS (K811872)ETHICON, Inc.1981-08-12
IONESCU-SHILEY PERICARDIAL PATCH (K801764)Shiley, Inc.1980-08-13
SCI MED PERICARDIAL SUBSTITUTE (K791792)Scimed Life Systems, Inc.1979-12-07
PATCH FABRIC (K770835)Usci, Div. C.R. Bard, Inc.1977-10-05
FELT, SURGICAL DACRON (K760516)Meadox Medicals, Div. Boston Scientific Corp.1977-01-05

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