# K963503: CTS Midcab Coronary Shunt

- Pathway: 510(k) (Traditional)
- Applicant: Cardiothoracic Systems, Inc.
- Decided: Apr 3, 1997 after 212 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) Bio-Vascular, Inc. Flo-Rester: named in the summary without a submission number
- (no number) Research Medical, Inc. Yacoubian Clamp External Coronary Artery Occluder: named in the summary without a submission number
- (no number) Research Medical, Inc. Carotid Artery Shunts: named in the summary without a submission number
- (no number) Research Medical, Inc. Vacu-Sponge Surgical Sponge: named in the summary without a submission number

## Indications for use
The CTS MIDCAB Coronary Shunt is intended to be used during minimally invasive direct coronary artery bypass (“MIDCAB”) procedures in conjunction with or without the CTS MIDCAB™ Access Platform and Stabilizer. The CTS Coronary Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy. This CTS Coronary Shunt 1s not an implant and is removed prior to completion of the surgery.

Source page: https://510kreport.com/device/K963503
Methodology: https://510kreport.com/methodology