# K964251: Occlusion Clamp** Device

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: May 23, 1997 after 211 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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 K920936 (1992). 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)
- K920936: Rmi External Coronary Artery Occluder, Research Medical, Inc. (1992) Summary page 1.

## Indications for use
The AUTO SUTURE* Occluding Clamp** device is intended for use in those patients undergoing coronary artery bypass surgery when the surgeon determines that it is desirable to temporarily occlude a coronary artery to optimize the exposure during the anastomosis.

Source page: https://510kreport.com/device/K964251
Methodology: https://510kreport.com/methodology