FDA product code PAW: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
PAW is the FDA product code for nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under PAW, 1 in the last five years, from 3 different applicants. The average 510(k) review took 105 days (median 121); 150 days on average over the last three years. FDA has posted 1 recall for PAW devices.
Definition
To repair or replace chordae tendinae.
Classification
| Field | Value |
|---|---|
| Device name | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement |
| Device class | Class II |
| Regulation | 21 CFR 870.3470 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for PAW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 150 |
Compare with all 510(k) review times · Search every PAW clearance
Top PAW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chawla Heart Technologies, LLC | 1 | 2025-12-04 |
| On-X Life Technologies, Inc. | 1 | 2014-06-06 |
| On-Xlifetechnologies | 1 | 2012-08-16 |
Most recent PAW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252126 | Chawla Heart Technologies, LLC | MitraPatch Mitral Valve Repair System | 2025-12-04 | 150 |
| K141060 | On-X Life Technologies, Inc. | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT | 2014-06-06 | 43 |
| K121173 | On-Xlifetechnologies | CHORD-X EPTFE SUTURE | 2012-08-16 | 121 |
Recalls for PAW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-12-13.
Frequently asked questions
What is FDA product code PAW?
PAW is the FDA product code for nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel.
What device class is PAW?
Class II, regulation 21 CFR 870.3470. Typical premarket route: 510(k).
How long does a 510(k) take for product code PAW?
Across 3 cleared submissions the average was 105 days from receipt to decision (median 121).
Which companies have the most PAW clearances?
Chawla Heart Technologies, LLC (1); On-X Life Technologies, Inc. (1); On-Xlifetechnologies (1).
Have PAW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-12-13.
Next steps
- Run an FDA pathway report with predicate devices for product code PAW
- Run a recall and safety report across every PAW manufacturer
- Watch product code PAW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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