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

- Device class: 2; regulation: 21 CFR 870.3470; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 150 days (middle half 150–150)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2012: 1
- 2014: 1
- 2025: 1

## Most-cited predicates
- K141060: Chord-X Pre-Measured Loops for Mitral Chordal Replacement (2014), cited by 1

Source page: https://510kreport.com/product-code/PAW
Data by year (CSV): https://510kreport.com/product-code/PAW.csv