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) → PAW — Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

# PAW · Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

_Cardiovascular · 21 CFR 870.3470 · Class 2_

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

## Overview

- **Product Code:** PAW
- **Device Name:** Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
- **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
- **Life-sustaining:** 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252126](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PAW/K252126.md) | MitraPatch Mitral Valve Repair System | Chawla Heart Technologies, LLC | Dec 4, 2025 | SESE |
| [K141060](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PAW/K141060.md) | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT | On-X Life Technologies, Inc. | Jun 6, 2014 | SESE |
| [K121173](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PAW/K121173.md) | CHORD-X EPTFE SUTURE | On-Xlifetechnologies | Aug 16, 2012 | SESE |

## Top Applicants

- Chawla Heart Technologies, LLC — 1 clearance
- On-X Life Technologies, Inc. — 1 clearance
- On-Xlifetechnologies — 1 clearance

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

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