# LOG: Catheter, Balloon For Retinal Reattachment

- 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)
- 1983: 1
- 1985: 1
- 1986: 1
- 1994: 1

## Most-cited predicates
- P820009: Lincoff-Design Scleral Buckling Balloon Catheter (1983), cited by 1

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