# K993892: Duraglide Stone Removal Balloon, Model 000635-38, 000646-47, Duraglide Stone Balloon, Model 007124-25,007144-45

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 6, 2000 after 51 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 K920342 (1992). 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)
- K920342: Bard Stone Removal Balloon Catheter, C.R. Bard, Inc. (1992) Summary page 1.

## Indications for use
For removal of biliary stones from the common bile duct.

Source page: https://510kreport.com/device/K993892
Methodology: https://510kreport.com/methodology