# K110122: Mustang Balloon Dilataion Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: May 12, 2011 after 114 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 K993303 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993303: Semi Compliant (SC) 35 Balloon Dilatation Catheter, Boston Scientific Corp (2000) Summary page 1.

## Most influential descendants
- K141597: Mustang Balloon Dialation Catheter (2014), 0 descendants of its own
- K112701: Charger Balloon Dilatation Catheter (2011), 0 descendants of its own

## Indications for use
The Mustang Balloon Dilatation Catheters with balloons up to 120 mm in length are indicated for the treatment of biliary strictures.

Source page: https://510kreport.com/device/K110122
Methodology: https://510kreport.com/methodology