# K070126: Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Sentreheart, Inc.
- Decided: Feb 8, 2008 after 388 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K781772 (1979). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032869: Cook Coda Balloon Catheter, Cook, Inc. (2003) Summary page 2.
- K021721: Equalizer Balloon Catheter, Boston Scientific Corp (2002) Summary page 2.
- K993292: Boston Scientific/Target Sentry Occlusion Balloon Catheter, Boston Scientific, Target (2000) Summary page 2.

## Indications for use
The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.

Source page: https://510kreport.com/device/K070126
Methodology: https://510kreport.com/methodology