# K970638: CTS Midcab Fixedn Diameter Coronary Shunt

- Pathway: 510(k) (Traditional)
- Applicant: Cardiothoracic Systems, Inc.
- Decided: Oct 30, 1997 after 252 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.
19 later devices descend from it; 2 cite it directly.
0 of 20 devices 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

## Most influential descendants
- K061075: Boomerang Wire (2006), 13 descendants of its own
- K091006: Itg Vascular Access System, Model 300 (2010), 12 descendants of its own
- K100615: Arstasis Access System (2010), 11 descendants of its own
- K102728: Arstasis Access System (2010), 10 descendants of its own
- K103143: Arstasis One Latchwire Access System (2011), 9 descendants of its own

## Indications for use
The CTS FloCoil 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 FloCoil Shunt is not an implant and is removed prior to completion of the anastomosis.

Source page: https://510kreport.com/device/K970638
Methodology: https://510kreport.com/methodology