# K112994: Cre Ditatation Ballon

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Feb 10, 2012 after 126 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974788 (1998). 4 ancestors in all.
15 later devices descend from it; 10 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110833: Cre Balloon Dilatation Catheter, Boston Scientific Corporation (2011)
- K001338: Microvasive Rapid Exchange Biliary Balloon Dilatation Catheter, Boston Scientific Corp (2000) Summary page 1.
- K910931: Biliary Balloon Dilatation Catheter, Boston Scientific Corp (1991) Summary page 1.

## Most influential descendants
- 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
- K172520: CRE RX Biliary Balloon Dilatation Catheter (2017), 1 descendant of its own
- K150142: Single Use Balloon Dilator V (with Knife) (2015), 1 descendant of its own

## Recalls of this device
- May 21, 2026 · Class II · Z-2628-2026: Potential sterile breach of the pouches in which devices are packaged.
- May 21, 2026 · Class II · Z-2631-2026: Potential sterile breach of the pouches in which devices are packaged.
- May 21, 2026 · Class II · Z-2630-2026: Potential sterile breach of the pouches in which devices are packaged.
- May 21, 2026 · Class II · Z-2627-2026: Potential sterile breach of the pouches in which devices are packaged.
- May 21, 2026 · Class II · Z-2626-2026: Potential sterile breach of the pouches in which devices are packaged.
- May 21, 2026 · Class II · Z-2629-2026: Potential sterile breach of the pouches in which devices are packaged.

## Indications for use
The CRETM Wireguided Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in. adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Source page: https://510kreport.com/device/K112994
Methodology: https://510kreport.com/methodology