# K172520: CRE RX Biliary Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Oct 4, 2017 after 44 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: 3 generations back to K974788 (1998). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112994: Cre Ditatation Ballon, Boston Scientific Corporation (2012) Summary page 4.
- K130484: Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary Catheter, Boston Scientific Corp (2013) Summary page 4.

## Most influential descendants
- K241888: Single-use Balloon Dilatation Catheter (2024), 0 descendants of its own

## Indications for use
CRE™ RX Biliary Balloon Dilatation Catheter is indicated for use in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. The CRE™ RX Biliary Balloon Dilatation Catheters may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.

Source page: https://510kreport.com/device/K172520
Methodology: https://510kreport.com/methodology