DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Class II
FDA product code DXZ covers "Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene", a Class II medical device regulated under 21 CFR 870.3470. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |