# K960923: Carbomedics Mitral Rotator

- Pathway: 510(k) (Traditional)
- Applicant: Carbomedics, Inc.
- Decided: Apr 29, 1996 after 54 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). Our OCR of the scanned summary read “1(95136__‘_” beside “510(k)”; FDA’s K951368 is the only number that fits it and carries the summary’s name for the device.

Source page: https://510kreport.com/device/K960923
Methodology: https://510kreport.com/methodology