# DTJ: Holder, Heart-Valve, Prosthesis

- Device class: 1; regulation: 21 CFR 870.3935; FDA's rule: 510(k) exempt
- FDA decisions: 12
- 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)
- 1979: 2
- 1981: 3
- 1986: 1
- 1987: 1
- 1988: 1
- 1994: 1
- 1995: 1
- 1996: 2

## Most-cited predicates
- K942736: Carbomedics (R) Prosthetic Heart Valve Holder Handle (1994), cited by 1
- K962154: Carbomedics Handle (1996), cited by 1

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