# K962858: Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number Ecpb-a) Antegrade/Retrograde System

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Sep 30, 1996 after 70 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
Longest line of descent: 2 generations back to K811411 (1981). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955132: Heartport Endoaortic Clamp, Heartport, Inc. (1996) Summary page 1.
- K961245: Heartport Endopulmonary Vent, Heartport, Inc. (1996) Summary page 1.
- K955121: Heartport Endoarterial Return Cannual, Heartport, Inc. (1996) Summary page 1.
- K875353: Percutaneous Arterial/Venous Cannula Placement Kit, Dlp, Inc. (1988) Summary page 1.
- K961270: Heartport Endosinus Catheter, Heartport, Inc. (1996) Summary page 1.

## Indications for use
The Heartport Endovascular Cardiopulmonary Bypass Systems are indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass and an arrested heart. The system consists of a set of catheters, cannulae and accessories that permits a patient to be maintained on cardiopulmonary bypass and the patient’s heart to be arrested without the need for a median sternotomy.

Source page: https://510kreport.com/device/K962858
Methodology: https://510kreport.com/methodology