Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3470](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3470) → DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene # DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene _Cardiovascular · 21 CFR 870.3470 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ ## Overview - **Product Code:** DXZ - **Device Name:** Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene - **Regulation:** [21 CFR 870.3470](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3470) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K240775.md) | PeriBeam® Pericardial Membrane | Tamabio | Apr 18, 2025 | SESE | | [K200955](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K200955.md) | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | Vascutek, Ltd. | Jul 8, 2020 | SESE | | [K162506](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K162506.md) | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | Mar 9, 2017 | SESE | | [K162579](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K162579.md) | VascuCel | Admedus Regen Pty, Ltd. | Oct 14, 2016 | SESE | | [K152127](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K152127.md) | CorMatrix Tyke | Cormatrix Cardiovascular, Inc. | Feb 4, 2016 | SESE | | [K151865](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K151865.md) | PremiPatch PTFE Pledget | Aesculap, Inc. | Oct 27, 2015 | SESE | | [K142447](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K142447.md) | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | Jan 7, 2015 | SESE | | [K142461](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K142461.md) | VASCU-GUARD Peripheral Vascular Patch | Synovis Life Technologies, Inc. | Nov 25, 2014 | SESE | | [K140789](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K140789.md) | CORMATRIX ECM FOR VASCULAR REPAIR | Cormatrix Cardiovascular, Inc. | Jul 15, 2014 | SESE | | [K130872](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K130872.md) | CARDIOCEL | Celxcel Pty, Ltd. | Jan 30, 2014 | SESE | | [K122306](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K122306.md) | SYNOVIS COLLAGEN MATRIX (TBD) | Synovis Surgical Innovations | Mar 8, 2013 | SESE | | [K122105](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K122105.md) | SMI CARDIOVASCULAR PATCH | Solinas Medical, Inc. | Dec 7, 2012 | SESE | | [K112683](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K112683.md) | SMI CARDIOVASCULAR PACH | Solimas Medical, Inc. | Dec 14, 2011 | SESE | | [K111187](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K111187.md) | PATCH, PLEDGET AND INTRACARDIAC | Cormatrix Cardiovascular, Inc. | Jul 26, 2011 | SESE | | [K101740](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K101740.md) | ALBOSURE POLYESTER VASCULAR PATCH | LeMaitre Vascular, Inc. | Sep 20, 2010 | SESE | | [K101866](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K101866.md) | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | Cryolife, Inc. | Jul 23, 2010 | SESE | | [K090637](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K090637.md) | CARDIO-WRAP | Mast Biosurgery USA, Inc. | Jan 7, 2010 | SESU | | [K091626](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K091626.md) | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH | Cryolife, Inc. | Aug 7, 2009 | SESE | | [K082139](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K082139.md) | EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 | Edwards Lifesciences, LLC | Oct 23, 2008 | SESE | | [K081438](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K081438.md) | 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 - Cormatrix Cardiovascular, Inc. — 5 clearances - Meadox Medicals, Div. Boston Scientific Corp. — 5 clearances - Bio-Vascular, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com