# K011018: Taut Balloon Catheter, Model 50640

- Pathway: 510(k) (Traditional)
- Applicant: Taut, Inc.
- Decided: Jun 22, 2001 after 79 days
- Product code: GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection)
- 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K173414: Advance Biliary Balloon Catheter (2018), 1 descendant of its own
- K212582: SpyGlass Discover Balloon Dilation Catheter (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K011018
Methodology: https://510kreport.com/methodology