# K112701: Charger Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Oct 25, 2011 after 39 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: 2 generations back to K993303 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110122: Mustang Balloon Dilataion Catheters, Boston Scientific (2011) Summary page 2.

## Indications for use
Charger 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/K112701
Methodology: https://510kreport.com/methodology