# K964248: Heartport Endocoronary Sinus Cathetr

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Jan 22, 1997 after 90 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
Longest line of descent: 2 generations back to K810360 (1981). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961270: Heartport Endosinus Catheter, Heartport, Inc. (1996) Summary page 1.

## Most influential descendants
- K090869: Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TD (2009), 0 descendants of its own

## Recalls of this device
- Jun 15, 2011 · Not classified · Z-2776-2011: Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.
- Dec 3, 2010 · Not classified · Z-0991-2011: Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.

## Indications for use
The catheter is designed to provide occlusion of the coronary sinus, to deliver cardioplegic solution to the coronary sinus and to monitor the coronary sinus pressure during cardiopulmonary bypass.

Source page: https://510kreport.com/device/K964248
Methodology: https://510kreport.com/methodology