# PWR: Catheter Repair Kit

- Device class: 2; regulation: 21 CFR 880.5970
- FDA decisions: 0
- Recalls: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)

## Most-cited predicates

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