DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cardiovascular · 21 CFR 870.3470 · Class 2
Overview
| Product Code | DXZ |
|---|---|
| Device Name | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Regulation | 21 CFR 870.3470 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 90)
Showing 20 most recent of 90 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240775 | PeriBeam® Pericardial Membrane | Tamabio | Apr 18, 2025 | SESE |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | Vascutek, Ltd. | Jul 8, 2020 | SESE |
| K162506 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | Mar 9, 2017 | SESE |
| K162579 | VascuCel | Admedus Regen Pty, Ltd. | Oct 14, 2016 | SESE |
| K152127 | CorMatrix Tyke | Cormatrix Cardiovascular, Inc. | Feb 4, 2016 | SESE |
| K151865 | PremiPatch PTFE Pledget | Aesculap, Inc. | Oct 27, 2015 | SESE |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | Jan 7, 2015 | SESE |
| K142461 | VASCU-GUARD Peripheral Vascular Patch | Synovis Life Technologies, Inc. | Nov 25, 2014 | SESE |
| K140789 | CORMATRIX ECM FOR VASCULAR REPAIR | Cormatrix Cardiovascular, Inc. | Jul 15, 2014 | SESE |
| K130872 | CARDIOCEL | Celxcel Pty, Ltd. | Jan 30, 2014 | SESE |
| K122306 | SYNOVIS COLLAGEN MATRIX (TBD) | Synovis Surgical Innovations | Mar 8, 2013 | SESE |
| K122105 | SMI CARDIOVASCULAR PATCH | Solinas Medical, Inc. | Dec 7, 2012 | SESE |
| K112683 | SMI CARDIOVASCULAR PACH | Solimas Medical, Inc. | Dec 14, 2011 | SESE |
| K111187 | PATCH, PLEDGET AND INTRACARDIAC | Cormatrix Cardiovascular, Inc. | Jul 26, 2011 | SESE |
| K101740 | ALBOSURE POLYESTER VASCULAR PATCH | LeMaitre Vascular, Inc. | Sep 20, 2010 | SESE |
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | Cryolife, Inc. | Jul 23, 2010 | SESE |
| K090637 | CARDIO-WRAP | Mast Biosurgery USA, Inc. | Jan 7, 2010 | SESU |
| K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH | Cryolife, Inc. | Aug 7, 2009 | SESE |
| K082139 | EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 | Edwards Lifesciences, LLC | Oct 23, 2008 | SESE |
| K081438 | MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT | Lifenet Health | Oct 17, 2008 | SESE |
Top Applicants
- W. L. Gore & Associates, Inc. — 13 clearances
- Chase Medical, Inc. — 7 clearances
- Meadox Medicals, Div. Boston Scientific Corp. — 5 clearances
- Cormatrix Cardiovascular, Inc. — 5 clearances
- Bio-Vascular, Inc. — 4 clearances
