PAW · Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Cardiovascular · 21 CFR 870.3470 · Class 2
Overview
| Product Code | PAW |
|---|---|
| Device Name | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement |
| Regulation | 21 CFR 870.3470 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | MitraPatch Mitral Valve Repair System | Chawla Heart Technologies, LLC | Dec 4, 2025 | SESE |
| K141060 | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT | On-X Life Technologies, Inc. | Jun 6, 2014 | SESE |
| K121173 | 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
