DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Class II
FDA Device Classification
Classification Details
- Product Code
- DXZ
- Device Class
- Class II
- Regulation Number
- 870.3470
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K240775 | tamabio | PeriBeam® Pericardial Membrane | April 18, 2025 |
| K200955 | vascutek | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | July 8, 2020 |
| K162506 | cryolife | PhotoFix Decellularized Bovine Pericardium | March 9, 2017 |
| K162579 | admedus regen pty | VascuCel | October 14, 2016 |
| K152127 | cormatrix cardiovascular | CorMatrix Tyke | February 4, 2016 |
| K151865 | aesculap | PremiPatch PTFE Pledget | October 27, 2015 |
| K142447 | synovis life technologies | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | January 7, 2015 |
| K142461 | synovis life technologies | VASCU-GUARD Peripheral Vascular Patch | November 25, 2014 |
| K140789 | cormatrix cardiovascular | CORMATRIX ECM FOR VASCULAR REPAIR | July 15, 2014 |
| K130872 | celxcel pty | CARDIOCEL | January 30, 2014 |
| K122306 | synovis surgical innovations | SYNOVIS COLLAGEN MATRIX (TBD) | March 8, 2013 |
| K122105 | solinas medical | SMI CARDIOVASCULAR PATCH | December 7, 2012 |
| K112683 | solimas medical | SMI CARDIOVASCULAR PACH | December 14, 2011 |
| K111187 | cormatrix cardiovascular | PATCH, PLEDGET AND INTRACARDIAC | July 26, 2011 |
| K101740 | lemaitre vascular | ALBOSURE POLYESTER VASCULAR PATCH | September 20, 2010 |
| K101866 | cryolife | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | July 23, 2010 |
| K090637 | mast biosurgery usa | CARDIO-WRAP | January 7, 2010 |
| K091626 | cryolife | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH | August 7, 2009 |
| K082139 | edwards lifesciences | EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 | October 23, 2008 |
| K081438 | lifenet health | MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT | October 17, 2008 |