# K962154: Carbomedics Handle

- Pathway: 510(k) (Traditional)
- Applicant: Carbomedics, Inc.
- Decided: Aug 27, 1996 after 84 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
Longest line of descent: 1 generation back to K942736 (1994). 1 ancestor in all.
1 later device descends 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)
- K942736: Carbomedics (R) Prosthetic Heart Valve Holder Handle, Carbomedics, Inc. (1994) Summary page 1.

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

## Indications for use
The CarboMedics Handle is intended for use with the CarboMedics Valve Holder (referred to herein as the "Valve Holder") for the purpose of assuring a firm grasp of the valve and to facilitate sewing ring exposure.

Source page: https://510kreport.com/device/K962154
Methodology: https://510kreport.com/methodology