# K961245: Heartport Endopulmonary Vent

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Jun 18, 1996 after 78 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 K811411 (1981). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K845046: Pul,Monary Artery Vent Catheter, Dlp, Inc. (1985) Summary page 1.
- K811411: Swan-Ganz Heparin Coated, Etc. Catheter, American Edwards Laboratories (1981) Summary page 1.
- (no number) Edslab Pulmonary Artery Catheter: named in the summary without a submission number

## Most influential descendants
- K962858: Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number Ecpb-a) Antegrade/Retrograde System (1996), 0 descendants of its own

## Indications for use
Intended for the removal of blood from the pulmonary artery and decompression of the heart during endovascular cardiopulmonary bypass.

Source page: https://510kreport.com/device/K961245
Methodology: https://510kreport.com/methodology