# K970611: Origin Cardiac Stablizer Occluder

- Pathway: 510(k) (Traditional)
- Applicant: Origin Medsystems, Inc.
- Decided: Aug 19, 1997 after 182 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CardioThoracic System’s (CTS) Stabilizer: named in the summary without a submission number
- (no number) Pilling’s Micro Anastomosis Clamp: named in the summary without a submission number

## Indications for use
The Origin Cardiac Stabilizer Occluder is indicated for use in cardiac surgery performed on the beating heart where local stabilization is required and a vessel may be temporarily occluded.

Source page: https://510kreport.com/device/K970611
Methodology: https://510kreport.com/methodology