PAW — Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement Class II
FDA product code PAW covers "Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement", a Class II medical device regulated under 21 CFR 870.3470. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PAW
- Device Class
- Class II
- Regulation Number
- 870.3470
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Definition
To repair or replace chordae tendinae.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252126 | chawla heart technologies | MitraPatch Mitral Valve Repair System | December 4, 2025 |
| K141060 | on-x life technologies | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT | June 6, 2014 |
| K121173 | on-xlifetechnologies | CHORD-X EPTFE SUTURE | August 16, 2012 |