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) → PSQ — Intracardiac Patch Or Pledget, Biologically Derived

# PSQ · Intracardiac Patch Or Pledget, Biologically Derived

_Cardiovascular · 21 CFR 870.3470 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ

## Overview

- **Product Code:** PSQ
- **Device Name:** Intracardiac Patch Or Pledget, Biologically Derived
- **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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K221032](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ/K221032.md) | Vascu-Guard Vascular Repair Patch | Synovis Life Technologies, Inc. | Oct 19, 2022 | SESE |
| [K221029](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ/K221029.md) | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | Oct 19, 2022 | SESE |
| [K210331](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ/K210331.md) | CardiaMend Pericardial and Epicardial Reconstruction Matrix | Helios Cardio, Inc. | Dec 21, 2021 | SESE |
| [K200566](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ/K200566.md) | ADAPT Tissue | Admedus Regen Pty, Ltd. | Apr 3, 2020 | SESE |
| [K190882](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ/K190882.md) | XenoSure Biologic Patch | Lemaitre Vascular | Feb 13, 2020 | SESE |
| [K191734](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ/K191734.md) | MatriStem UBM Pericardial Patch | Acell, Inc. | Nov 22, 2019 | SESE |
| [K183635](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ/K183635.md) | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | Feb 14, 2019 | SESE |
| [K181038](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ/K181038.md) | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) | Cormatrix Cardiovascular, Inc. | Oct 10, 2018 | SESE |
| [K172085](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ/K172085.md) | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | Dec 4, 2017 | SESE |
| [K172660](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ/K172660.md) | Duravess bovine pericardial vascular patch | Edwards Lifesciences, LLC | Nov 17, 2017 | SESE |
| [K170951](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ/K170951.md) | CardioCel 3D | Admedus Regen Pty, Ltd. | Apr 28, 2017 | SESE |

## Top Applicants

- Admedus Regen Pty, Ltd. — 2 clearances
- Cryolife, Inc. — 2 clearances
- Synovis Life Technologies, Inc. — 2 clearances
- Acell, Inc. — 1 clearance
- Cormatrix Cardiovascular, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PSQ)

**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