FDA Product Code
FDA Product Code DXZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3470
510(k) Clearances — 90 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240775 | PeriBeam® Pericardial Membrane | Tamabio | 2025-04-18 | Traditional | PDF ↗ |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | Vascutek, Ltd. | 2020-07-08 | Traditional | PDF ↗ |
| K162506 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2017-03-09 | Traditional | PDF ↗ |
| K162579 | VascuCel | Admedus Regen Pty, Ltd. | 2016-10-14 | Special | PDF ↗ |
| K152127 | CorMatrix Tyke | Cormatrix Cardiovascular, Inc. | 2016-02-04 | Traditional | PDF ↗ |
| K151865 | PremiPatch PTFE Pledget | Aesculap, Inc. | 2015-10-27 | Traditional | PDF ↗ |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | 2015-01-07 | Traditional | PDF ↗ |
| K142461 | VASCU-GUARD Peripheral Vascular Patch | Synovis Life Technologies, Inc. | 2014-11-25 | Traditional | PDF ↗ |
| K140789 | CORMATRIX ECM FOR VASCULAR REPAIR | Cormatrix Cardiovascular, Inc. | 2014-07-15 | Traditional | PDF ↗ |
| K130872 | CARDIOCEL | Celxcel Pty, Ltd. | 2014-01-30 | Traditional | PDF ↗ |
| K122306 | SYNOVIS COLLAGEN MATRIX (TBD) | Synovis Surgical Innovations | 2013-03-08 | Traditional | PDF ↗ |
| K122105 | SMI CARDIOVASCULAR PATCH | Solinas Medical, Inc. | 2012-12-07 | Special | PDF ↗ |
| K112683 | SMI CARDIOVASCULAR PACH | Solimas Medical, Inc. | 2011-12-14 | Traditional | PDF ↗ |
| K111187 | PATCH, PLEDGET AND INTRACARDIAC | Cormatrix Cardiovascular, Inc. | 2011-07-26 | Traditional | PDF ↗ |
| K101740 | ALBOSURE POLYESTER VASCULAR PATCH | LeMaitre Vascular, Inc. | 2010-09-20 | Traditional | PDF ↗ |
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | Cryolife, Inc. | 2010-07-23 | Special | PDF ↗ |
| K090637 | CARDIO-WRAP | Mast Biosurgery USA, Inc. | 2010-01-07 | Traditional | PDF ↗ |
| K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH | Cryolife, Inc. | 2009-08-07 | Traditional | PDF ↗ |
| K082139 | EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 | Edwards Lifesciences, LLC | 2008-10-23 | Traditional | PDF ↗ |
| K081438 | MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT | Lifenet Health | 2008-10-17 | Traditional | PDF ↗ |
| K063349 | CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR | Cormatrix Cardiovascular, Inc. | 2007-02-16 | Traditional | PDF ↗ |
| K060396 | IVENA VASCULAR PATCH | Atrium Medical Corp. | 2006-05-12 | Traditional | PDF ↗ |
| K052416 | PERIPRO PATCH | Hancock/Jaffe Laboratories | 2005-10-25 | Traditional | PDF ↗ |
| K051405 | REGENSIS PERICARDIAL PATCH | Cormatrix Cardiovascular, Inc. | 2005-08-31 | Traditional | PDF ↗ |
| K041736 | PFA PATCH | Peritec Biosciences, LLC | 2005-01-13 | Traditional | PDF ↗ |
| K041716 | PTFE FELTS AND PLEDGETS | Boston Scientific Corp | 2004-07-22 | Special | PDF ↗ |
| K040415 | PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT | Synovis Surgical Innovations | 2004-04-14 | Traditional | PDF ↗ |
| K040162 | CORRESTORE PATCH SYSTEM | Somanetics Corp. | 2004-03-16 | Traditional | PDF ↗ |
| K031948 | PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 | Pm Devices, Inc. | 2003-09-16 | Traditional | PDF ↗ |
| K031586 | CORRESTORE PATCH SYSTEM | Somanetics Corp. | 2003-08-07 | Traditional | PDF ↗ |
| K022093 | CHASE CARDIOVASCULAR PATCH KIT | Chase Medical, Inc. | 2002-09-20 | Traditional | PDF ↗ |
| K021129 | CHARE CARIOVASCULAR PATCH | Chase Medical, Inc. | 2002-06-03 | Traditional | PDF ↗ |
| K020233 | CHASE CARDIOVASCULAR PATCH KIT | Chase Medical, Inc. | 2002-03-14 | Traditional | PDF ↗ |
| K020132 | CHASE CARDIOVASCULAR PATCH KIT | Chase Medical, Inc. | 2002-02-26 | Traditional | PDF ↗ |
| K011487 | CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS | Somanetics Corp. | 2001-11-21 | Traditional | PDF ↗ |
| K012098 | PRECLUDE PERICARDIAL MEMBRANE | W. L. Gore & Associates, Inc. | 2001-09-20 | Traditional | PDF ↗ |
| K012248 | CHASE CARDIOVASCULAR PATCH | Chase Medical, Inc. | 2001-08-10 | Traditional | PDF ↗ |
| K003467 | CHASE CARDIOVASCULAR PATCH | Chase Medical, Inc. | 2001-01-29 | Traditional | PDF ↗ |
| K001785 | SURGISIS PERIPHERAL VASCULAR PATCH | Cook Biotech, Inc. | 2000-12-27 | Traditional | PDF ↗ |
| K003070 | ETHIBOND EXCEL VALVE LOOP SUTURE | ETHICON, Inc. | 2000-11-07 | Traditional | PDF ↗ |
| K001662 | CHASE CARDIOVASCULAR PATCH | Chase Medical, Inc. | 2000-08-02 | Traditional | PDF ↗ |
| K994032 | FLUORO-TEX CARDIOVASCULAR PATCH | Bridger Biomed, Inc. | 2000-07-07 | Traditional | PDF ↗ |
| K993288 | SULZER CARBOMEDICS CARDIOFIX PERICARDIUM | Sulzer Carbomedics, Inc. | 1999-12-29 | Traditional | PDF ↗ |
| K992776 | UNI-GRAFT K DV PATCH | Atrium Medical Corp. | 1999-11-16 | Traditional | PDF ↗ |
| K984526 | ACUSEAL CARDIOVASCULAR PATCH | W. L. Gore & Associates, Inc. | 1999-04-08 | Traditional | PDF ↗ |
| K983602 | CV PERI-GUARD AND VASCU-GUARD | Bio-Vascular, Inc. | 1998-11-12 | Special | PDF ↗ |
| K982810 | SHELHIGH NO-REACT VASCUPATCH | Shelhigh, Inc. | 1998-10-28 | Traditional | PDF ↗ |
| K974914 | SHELHIGH NO-REACT PERICARDIAL PATCHES | Shelhigh, Inc. | 1998-06-03 | Traditional | PDF ↗ |
| K972201 | PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE | Sulzer Carbomedics, Inc. | 1998-04-14 | Traditional | PDF ↗ |
| K971726 | CV PERI-GUARD - CARDIOVASCULAR PATCH | Bio-Vascular, Inc. | 1998-04-10 | Traditional | PDF ↗ |
| K973178 | FLUORO-TEX SURGICAL MEMBRANE | Bridger Biomed, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K963967 | GLYCAR PERICARDIAL PATCH | Glycar, Inc. | 1997-10-31 | Traditional | PDF ↗ |
| K963368 | GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE | Glycar, Inc. | 1997-10-31 | Traditional | PDF ↗ |
| K964467 | SHELHIGH PERICARDIAL PATCH | Shelhigh, Inc. | 1997-09-23 | Traditional | PDF ↗ |
| K963611 | VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH | Vascutek, Ltd. | 1996-11-21 | Traditional | PDF ↗ |
| K962342 | HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH | Meadox Medicals, Div. Boston Scientific Corp. | 1996-09-10 | Traditional | PDF ↗ |
| K955349 | HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-14 | Traditional | PDF ↗ |
| K953289 | TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET | Davis & Geck, Inc. | 1995-08-21 | Traditional | PDF ↗ |
| K953425 | POLYETHYLENE TEREPHTHALATE (PET) PLEDGET | Davis & Geck, Inc. | 1995-08-21 | Traditional | PDF ↗ |
| K943736 | CVPRO CARDIOVASCULAR PATCH | W. L. Gore & Associates, Inc. | 1995-02-22 | Traditional | PDF ↗ |
| K942010 | VASCU-GUARD | Bio-Vascular, Inc. | 1994-07-07 | Traditional | PDF ↗ |
| K940906 | GORE-TEX CARDIOVASCULAR PATCH | W. L. Gore & Associates, Inc. | 1994-05-18 | Traditional | PDF ↗ |
| K930950 | GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE | W. L. Gore & Associates, Inc. | 1993-10-22 | Traditional | PDF ↗ |
| K931386 | HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC | Meadox Medicals, Div. Boston Scientific Corp. | 1993-05-27 | Traditional | PDF ↗ |
| K921659 | ULTRA LOW POROSITY DACRON WOVEN PATCH | Intervascular, Inc. | 1992-11-25 | Traditional | PDF ↗ |
| K921895 | TISSUE PATCH, TISSUE GRAFT | Bio-Vascular, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K905073 | CARDIOVASCULAR REPAIR PATCH | Impra, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K914450 | GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE | W. L. Gore & Associates, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K914448 | GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE | W. L. Gore & Associates, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K912107 | GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM | W. L. Gore & Associates, Inc. | 1991-10-11 | Traditional | PDF ↗ |
| K910464 | GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE | W. L. Gore & Associates, Inc. | 1991-03-26 | Traditional | PDF ↗ |
| K905496 | WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS | Meadox Medicals, Div. Boston Scientific Corp. | 1991-03-11 | Traditional | PDF ↗ |
| K881508 | OCHSNER & MICRON FABRIC PATCH | Intervascular, Inc. | 1988-05-25 | Traditional | PDF ↗ |
| K842066 | PERI-GUARD PERICARDIAL PATCH | Genetic Laboratories, Inc. | 1985-12-30 | Traditional | PDF ↗ |
| K833763 | PERICARDIAL PATCH | American Edwards Laboratories | 1984-11-01 | Traditional | PDF ↗ |
| K840262 | HANCOCK PERICARDIAL PATCH | Extracorporeal Medical Specialities, Inc. | 1984-05-30 | Traditional | PDF ↗ |
| K831516 | GORE-TEX SURGICAL MEMBRANE | W. L. Gore & Associates, Inc. | 1984-01-06 | Traditional | PDF ↗ |
| K833021 | PERI-GUARD PERICARDIAL PATCH-HERNIA | Genetic | 1983-12-26 | Traditional | PDF ↗ |
| K830863 | HANCOCK PERICARDIAL PATCH | Extracorporeal Medical Specialities, Inc. | 1983-08-31 | Traditional | PDF ↗ |
| K830806 | VASCULAR GRAFT/BIFURCATED/FEP-RINGED | W. L. Gore & Associates, Inc. | 1983-08-13 | Traditional | PDF ↗ |
| K823345 | PATCH | Shiley, Inc. | 1983-03-10 | Traditional | PDF ↗ |
| K821717 | GORE-TES EXPANDED PTFE PATCH | W. L. Gore & Associates, Inc. | 1983-01-12 | Traditional | PDF ↗ |
| K821532 | PERIGUARD PERICARDIAL PATCH | Genetic Laboratories, Inc. | 1982-08-19 | Traditional | PDF ↗ |
| K811841 | GORE-TEX CARDIOVASCULAR PATCH | W. L. Gore & Associates, Inc. | 1981-09-16 | Traditional | PDF ↗ |
| K812254 | DACRON PLEDGET SUTURE BUTTRESS | ETHICON, Inc. | 1981-08-31 | Traditional | PDF ↗ |
| K811872 | TEFLON PLEDGET SUTURE BUTTRESS | ETHICON, Inc. | 1981-08-12 | Traditional | PDF ↗ |
| K801764 | IONESCU-SHILEY PERICARDIAL PATCH | Shiley, Inc. | 1980-08-13 | Traditional | PDF ↗ |
| K791792 | SCI MED PERICARDIAL SUBSTITUTE | Scimed Life Systems, Inc. | 1979-12-07 | Traditional | PDF ↗ |
| K770835 | PATCH FABRIC | Usci, Div. C.R. Bard, Inc. | 1977-10-05 | Traditional | PDF ↗ |
| K760516 | FELT, SURGICAL DACRON | Meadox Medicals, Div. Boston Scientific Corp. | 1977-01-05 | Traditional | PDF ↗ |
Product code DXZ · Class II · Cardiovascular. Data: openFDA.