# K981009: Heartport Endopulmonary Vent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Sep 4, 1998 after 170 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
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) Heartport® Endopulmonary Vent™ catheter: named in the summary without a submission number

## Indications for use
The Heartport Endopulmonary Vent Catheter is indicated for use in patients undergoing cardiopulmonary bypass. It is intended to remove blood from the pulmonary artery and assist in decompressing the heart.

Source page: https://510kreport.com/device/K981009
Methodology: https://510kreport.com/methodology