# K955126: Lmi Biliary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Lucas Medical, Inc.
- Decided: May 10, 1996 after 183 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: 1 generation back to K910917 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910917: Cathlab Silicone Biliary Balloon Catheter, Cathlab Corp. (1991) Summary page 1.

## Indications for use
The device is intended for intrg-operative short term use in the biliary trec to aid in the removal of ductal stones and debris.

Source page: https://510kreport.com/device/K955126
Methodology: https://510kreport.com/methodology