# K951368: Carbomedics Exended Mitral Rotator

- Pathway: 510(k) (Traditional)
- Applicant: Carbomedics, Inc.
- Decided: Jun 20, 1995 after 85 days
- Product code: MOP (Rotator, Prosthetic Heart Valve)
- 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K980016: Millennium Valve Introducer/Rotator Handle (1998), 0 descendants of its own
- K974648: Sulzer Carbomedics Low Profile Mitral Rotator (1998), 0 descendants of its own
- K960923: Carbomedics Mitral Rotator (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K951368
Methodology: https://510kreport.com/methodology