Product code DXZ
- Device name
- Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.3470
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240775 | PeriBeam® Pericardial Membrane | Tamabio | 2025-04-18 |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | Vascutek, Ltd. | 2020-07-08 |
| K162506 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2017-03-09 |
| K162579 | VascuCel | Admedus Regen Pty, Ltd. | 2016-10-14 |
| K152127 | CorMatrix Tyke | Cormatrix Cardiovascular, Inc. | 2016-02-04 |
| K151865 | PremiPatch PTFE Pledget | Aesculap, Inc. | 2015-10-27 |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | 2015-01-07 |
| K142461 | VASCU-GUARD Peripheral Vascular Patch | Synovis Life Technologies, Inc. | 2014-11-25 |
| K140789 | CORMATRIX ECM FOR VASCULAR REPAIR | Cormatrix Cardiovascular, Inc. | 2014-07-15 |
| K130872 | CARDIOCEL | Celxcel Pty, Ltd. | 2014-01-30 |
| K122306 | SYNOVIS COLLAGEN MATRIX (TBD) | Synovis Surgical Innovations | 2013-03-08 |
| K122105 | SMI CARDIOVASCULAR PATCH | Solinas Medical, Inc. | 2012-12-07 |
| K112683 | SMI CARDIOVASCULAR PACH | Solimas Medical, Inc. | 2011-12-14 |
| K111187 | PATCH, PLEDGET AND INTRACARDIAC | Cormatrix Cardiovascular, Inc. | 2011-07-26 |
| K101740 | ALBOSURE POLYESTER VASCULAR PATCH | LeMaitre Vascular, Inc. | 2010-09-20 |
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | Cryolife, Inc. | 2010-07-23 |
| K090637 | CARDIO-WRAP | Mast Biosurgery USA, Inc. | 2010-01-07 |
| K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH | Cryolife, Inc. | 2009-08-07 |
| K082139 | EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 | Edwards Lifesciences, LLC | 2008-10-23 |
| K081438 | MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT | Lifenet Health | 2008-10-17 |
| K063349 | CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR | Cormatrix Cardiovascular, Inc. | 2007-02-16 |
| K060396 | IVENA VASCULAR PATCH | Atrium Medical Corp. | 2006-05-12 |
| K052416 | PERIPRO PATCH | Hancock/Jaffe Laboratories | 2005-10-25 |
| K051405 | REGENSIS PERICARDIAL PATCH | Cormatrix Cardiovascular, Inc. | 2005-08-31 |
| K041736 | PFA PATCH | Peritec Biosciences, LLC | 2005-01-13 |
| K041716 | PTFE FELTS AND PLEDGETS | Boston Scientific Corp | 2004-07-22 |
| K040415 | PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT | Synovis Surgical Innovations | 2004-04-14 |
| K040162 | CORRESTORE PATCH SYSTEM | Somanetics Corp. | 2004-03-16 |
| K031948 | PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 | Pm Devices, Inc. | 2003-09-16 |
| K031586 | CORRESTORE PATCH SYSTEM | Somanetics Corp. | 2003-08-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10705031462403 | ETHIBOND EXCEL | ETHICON, LLC | 2019-07-04 |
| 10705031462373 | ETHIBOND EXCEL | ETHICON, LLC | 2019-07-04 |
| 10705031462366 | ETHIBOND EXCEL | ETHICON, LLC | 2019-07-04 |
| 10705031462359 | ETHIBOND EXCEL | ETHICON, LLC | 2019-07-04 |
| 10705031462335 | ETHIBOND EXCEL | ETHICON, LLC | 2019-07-04 |
| 10705031462304 | ETHIBOND EXCEL | ETHICON, LLC | 2019-07-04 |
| 10705031462281 | ETHIBOND EXCEL | ETHICON, LLC | 2019-07-04 |
| 10705031462229 | ETHIBOND EXCEL | ETHICON, LLC | 2019-07-04 |
| 10705031462212 | ETHIBOND EXCEL | ETHICON, LLC | 2019-07-04 |
| 10809160032589 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-09 |
| 10705031036116 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031047839 | ETHICON | Johnson & Johnson International Inc. | 2015-09-01 |
| 10705031047822 | ETHICON | Johnson & Johnson International Inc. | 2015-09-01 |
| 10705031047815 | ETHICON | Johnson & Johnson International Inc. | 2015-09-01 |
| 10705031047808 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031025783 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031034075 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031033863 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031033856 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031033122 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031031890 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031031678 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031031531 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031028739 | PROLENE | ETHICON, LLC | 2015-09-01 |
| 10705031027138 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031027008 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031026773 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031026681 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031026346 | ETHICON | ETHICON, LLC | 2015-09-01 |
| 10705031025875 | PROLENE | ETHICON, LLC | 2015-09-01 |