# K101877: Occlusion Balloon Catheter Model Obc

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Aug 6, 2010 after 31 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 K003495 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 1.

## Indications for use
The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.

Source page: https://510kreport.com/device/K101877
Methodology: https://510kreport.com/methodology