# OOB: Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 0 (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)
- 2024: 3
- 2025: 3
- 2026: 4

## Most-cited predicates

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