# K032869: Cook Coda Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Nov 19, 2003 after 65 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: 1 generation back to K003495 (2001). 2 ancestors in all.
26 later devices descend from it; 9 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002286: Ldob Occlusion Balloon Catheter, Cook, Inc. (2001) Summary page 1.
- K003495: Ancure Lliac Balloon Catheter, Guidant Cardiac and Vascular Surgery (2001) Summary page 1.

## Most influential descendants
- K122917: Coda Balloon Catheter (2013), 11 descendants of its own
- K050038: Reliant Stent Graft Balloon Catheter (2005), 11 descendants of its own
- K150970: Coda LP Balloon Catheter (2015), 10 descendants of its own
- K151821: ER-REBOA Catheter (2015), 9 descendants of its own
- K170411: ER-REBOA Catheter (2017), 8 descendants of its own

## Indications for use
The COOK CODA BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

Source page: https://510kreport.com/device/K032869
Methodology: https://510kreport.com/methodology