# K001338: Microvasive Rapid Exchange Biliary Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 30, 2000 after 125 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
No predicates in its family tree.
20 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K112994: Cre Ditatation Ballon (2012), 15 descendants of its own
- K151671: Disposable Multistage Dilation Balloon Catheter (2015), 4 descendants of its own
- K162226: Reliant Multistage Dilatation Balloon Catheter (2017), 3 descendants of its own
- K180418: Reliant (TM) Multistage Dilatation Balloon Catheter (2018), 2 descendants of its own
- K130484: Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary Catheter (2013), 2 descendants of its own

Source page: https://510kreport.com/device/K001338
Methodology: https://510kreport.com/methodology