# K033333: Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-B

- Pathway: 510(k) (Special)
- Applicant: Aomori Olympus Co., Ltd.
- Decided: Nov 14, 2003 after 29 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- 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 K904669 (1991). 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)
- K962925: Olympus B-5/B-7 Seriesballoon Catheter, Olympus America, Inc. (1996) Summary page 1.

## Most influential descendants
- K091495: Single Use 3-Lumen Extraction Balloon V, Model V B-V233P-a,B-V233P-B,B-V433P-a,B-V433P-B, BV243Q-a, B-V243Q-B, B-V443Q-a (2009), 0 descendants of its own

## Indications for use
These instruments have been designed to be used with Olympus endoscopes to inject contrast media into the biliary or pancreatic tract. They can also be used for retrieval of biliary or pancreatic stones.

Source page: https://510kreport.com/device/K033333
Methodology: https://510kreport.com/methodology