# K942736: Carbomedics (R) Prosthetic Heart Valve Holder Handle

- Pathway: 510(k) (Traditional)
- Applicant: Carbomedics, Inc.
- Decided: Jul 6, 1994 after 26 days
- Product code: DTJ (Holder, Heart-Valve, Prosthesis)
- Device class: 1
- Regulation: 21 CFR 870.3935
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962154: Carbomedics Handle (1996), 1 descendant of its own
- K980016: Millennium Valve Introducer/Rotator Handle (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K942736
Methodology: https://510kreport.com/methodology