# K974648: Sulzer Carbomedics Low Profile Mitral Rotator

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Carbomedics, Inc.
- Decided: Aug 4, 1998 after 235 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
Longest line of descent: 1 generation back to K951368 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951368: Carbomedics Exended Mitral Rotator, Carbomedics, Inc. (1995) Summary page 1.

## Indications for use
The Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CPHV™ mitral valve in situ when necessary to avoid anatomical obstruction.

Source page: https://510kreport.com/device/K974648
Methodology: https://510kreport.com/methodology