# K110833: Cre Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Apr 20, 2011 after 26 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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: 1 generation back to K974788 (1998). 1 ancestor in all.
17 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974788: Cre (TM) Balloon Dilatation Catheter, Boston Scientific Corp (1998) Summary page 4.

## 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
- K172520: CRE RX Biliary Balloon Dilatation Catheter (2017), 1 descendant of its own

## Recalls of this device
- May 21, 2026 · Class II · Z-2634-2026: Potential sterile breach of the pouches in which devices are packaged.
- May 21, 2026 · Class II · Z-2635-2026: Potential sterile breach of the pouches in which devices are packaged.
- May 21, 2026 · Class II · Z-2633-2026: Potential sterile breach of the pouches in which devices are packaged.
- May 21, 2026 · Class II · Z-2632-2026: Potential sterile breach of the pouches in which devices are packaged.
- May 21, 2026 · Class II · Z-2637-2026: Potential sterile breach of the pouches in which devices are packaged.
- May 21, 2026 · Class II · Z-2636-2026: Potential sterile breach of the pouches in which devices are packaged.

## Indications for use
Indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label referring to any combination of esophageal, pyloric and colonic dilatation.

Source page: https://510kreport.com/device/K110833
Methodology: https://510kreport.com/methodology