# GBA: Catheter, Balloon Type

- Device class: 1; regulation: 21 CFR 878.4200; FDA's rule: 510(k) exempt
- FDA decisions: 5
- 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)
- 1978: 1
- 1979: 2
- 1980: 1
- 1986: 1

## Most-cited predicates
- K781772: Catheter, Transluminal Balloon (1979), cited by 1

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