# K023880: Cardio Vations Steerable Coronary Sinus Catheter

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Dec 11, 2002 after 20 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 2 (0 Class I)
- 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) Endocoronary Sinus Catheter: named in the summary without a submission number

## Recalls of this device
- Jun 15, 2011 · Not classified · Z-2777-2011: Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.
- Dec 3, 2010 · Not classified · Z-0992-2011: Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.

## Indications for use
The Steerable Coronary Sinus Catheter is indicated for occlusion of the coronary sinus, delivery of cardioplegic solution, and monitoring of coronary sinus pressure during cardiopulmonary bypass.

Source page: https://510kreport.com/device/K023880
Methodology: https://510kreport.com/methodology