Panels › Cardiovascular › Product code DXZ · Class 2
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation 870.3470
0510(k)s in 12 months (90 all time)
3recalls in 12 months (21 all time)
20recalls that name a 510(k)
Top companies in DXZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 18, 2025 | K240775 | PeriBeam® Pericardial Membrane Tamabio, JP | DXZ |
| Jul 8, 2020 | K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch Vascutek, Ltd., GB | DXZ |
| Mar 9, 2017 | K162506 | PhotoFix Decellularized Bovine Pericardium Cryolife, Inc. | DXZ |
| Oct 14, 2016 | K162579 | VascuCel Admedus Regen Pty, Ltd., AU | DXZ |
| Feb 4, 2016 | K152127 | CorMatrix Tyke Cormatrix Cardiovascular, Inc. | DXZ |
| Oct 27, 2015 | K151865 | PremiPatch PTFE Pledget Aesculap, Inc. | DXZ |
| Jan 7, 2015 | K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch Synovis Life Technologies, Inc. | DXZ |
| Nov 25, 2014 | K142461 | VASCU-GUARD Peripheral Vascular Patch Synovis Life Technologies, Inc. | DXZ |
| Jul 15, 2014 | K140789 | CORMATRIX ECM FOR VASCULAR REPAIR Cormatrix Cardiovascular, Inc. | DXZ |
| Jan 30, 2014 | K130872 | CARDIOCEL Celxcel Pty, Ltd. | DXZ |
| Mar 8, 2013 | K122306 | SYNOVIS COLLAGEN MATRIX (TBD) Synovis Surgical Innovations | DXZ |
| Dec 7, 2012 | K122105 | SMI CARDIOVASCULAR PATCH Solinas Medical, Inc. | DXZ |
| Dec 14, 2011 | K112683 | SMI CARDIOVASCULAR PACH Solimas Medical, Inc. | DXZ |
| Jul 26, 2011 | K111187 | PATCH, PLEDGET AND INTRACARDIAC Cormatrix Cardiovascular, Inc. | DXZ |
| Sep 20, 2010 | K101740 | ALBOSURE POLYESTER VASCULAR PATCH LeMaitre Vascular, Inc. | DXZ |
| Jul 23, 2010 | K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH Cryolife, Inc. | DXZ |
| Jan 7, 2010 | K090637 | CARDIO-WRAP Mast Biosurgery USA, Inc. | DXZ |
| Aug 7, 2009 | K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH Cryolife, Inc. | DXZ |
| Oct 23, 2008 | K082139 | EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 Edwards Lifesciences, LLC | DXZ |
| Oct 17, 2008 | K081438 | MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT Lifenet Health | DXZ |
| Feb 16, 2007 | K063349 | CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR Cormatrix Cardiovascular, Inc. | DXZ |
| May 12, 2006 | K060396 | IVENA VASCULAR PATCH Atrium Medical Corp. | DXZ |
| Oct 25, 2005 | K052416 | PERIPRO PATCH Hancock/Jaffe Laboratories | DXZ |
| Aug 31, 2005 | K051405 | REGENSIS PERICARDIAL PATCH Cormatrix Cardiovascular, Inc. | DXZ |
| Jan 13, 2005 | K041736 | PFA PATCH Peritec Biosciences, LLC | DXZ |
| Jul 22, 2004 | K041716 | PTFE FELTS AND PLEDGETS Boston Scientific Corp | DXZ |
| Apr 14, 2004 | K040415 | PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT Synovis Surgical Innovations | DXZ |
| Mar 16, 2004 | K040162 | CORRESTORE PATCH SYSTEM Somanetics Corp. | DXZ |
| Sep 16, 2003 | K031948 | PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 Pm Devices, Inc., CA | DXZ |
| Aug 7, 2003 | K031586 | CORRESTORE PATCH SYSTEM Somanetics Corp. | DXZ |
| Sep 20, 2002 | K022093 | CHASE CARDIOVASCULAR PATCH KIT Chase Medical, Inc. | DXZ |
| Jun 3, 2002 | K021129 | CHARE CARIOVASCULAR PATCH Chase Medical, Inc. | DXZ |
| Mar 14, 2002 | K020233 | CHASE CARDIOVASCULAR PATCH KIT Chase Medical, Inc. | DXZ |
| Feb 26, 2002 | K020132 | CHASE CARDIOVASCULAR PATCH KIT Chase Medical, Inc. | DXZ |
| Nov 21, 2001 | K011487 | CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS Somanetics Corp. | DXZ |
| Sep 20, 2001 | K012098 | PRECLUDE PERICARDIAL MEMBRANE W. L. Gore & Associates, Inc. | DXZ |
| Aug 10, 2001 | K012248 | CHASE CARDIOVASCULAR PATCH Chase Medical, Inc. | DXZ |
| Jan 29, 2001 | K003467 | CHASE CARDIOVASCULAR PATCH Chase Medical, Inc. | DXZ |
| Dec 27, 2000 | K001785 | SURGISIS PERIPHERAL VASCULAR PATCH Cook Biotech, Inc. | DXZ |
| Nov 7, 2000 | K003070 | ETHIBOND EXCEL VALVE LOOP SUTURE ETHICON, Inc. | DXZ |
| Aug 2, 2000 | K001662 | CHASE CARDIOVASCULAR PATCH Chase Medical, Inc. | DXZ |
| Jul 7, 2000 | K994032 | FLUORO-TEX CARDIOVASCULAR PATCH Bridger Biomed, Inc. | DXZ |
| Dec 29, 1999 | K993288 | SULZER CARBOMEDICS CARDIOFIX PERICARDIUM Sulzer Carbomedics, Inc. | DXZ |
| Nov 16, 1999 | K992776 | UNI-GRAFT K DV PATCH Atrium Medical Corp. | DXZ |
| Apr 8, 1999 | K984526 | ACUSEAL CARDIOVASCULAR PATCH W. L. Gore & Associates, Inc. | DXZ |
| Nov 12, 1998 | K983602 | CV PERI-GUARD AND VASCU-GUARD Bio-Vascular, Inc. | DXZ |
| Oct 28, 1998 | K982810 | SHELHIGH NO-REACT VASCUPATCH Shelhigh, Inc. | DXZ |
| Jun 3, 1998 | K974914 | SHELHIGH NO-REACT PERICARDIAL PATCHES Shelhigh, Inc. | DXZ |
| Apr 14, 1998 | K972201 | PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE Sulzer Carbomedics, Inc. | DXZ |
| Apr 10, 1998 | K971726 | CV PERI-GUARD - CARDIOVASCULAR PATCH Bio-Vascular, Inc. | DXZ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.