# K961270: Heartport Endosinus Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Jun 18, 1996 after 77 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K810360 (1981). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K897137: Rmi Aortic Root/Coronary Sinus Pressure Monitoring, Research Medical, Inc. (1990) Summary page 1.
- K810360: Baim TM Coronary Sinus Flow Thermal, Electro-Catheter Corp. (1981) Summary page 1.

## Most influential descendants
- K964248: Heartport Endocoronary Sinus Cathetr (1997), 1 descendant of its own
- K090869: Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TD (2009), 0 descendants of its own
- K962858: Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number Ecpb-a) Antegrade/Retrograde System (1996), 0 descendants of its own

## Indications for use
Occlusion of the coronary sinus, delivery of cardioplegia, and monitoring of coronary sinus pressure during cardiopulmonary bypass.

Source page: https://510kreport.com/device/K961270
Methodology: https://510kreport.com/methodology