# K112697: Charger Pta Ballon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Nov 30, 2011 after 75 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001134 (2000). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103751: Mustang Balloon Dilatation Catheters, Boston Scientific (2011) Summary page 1.

## Most influential descendants
- K220410: Ebony HP PTA OTW 0.035 Catheter (2022), 0 descendants of its own

## Indications for use
The Charger Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subctavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Charger Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K112697
Methodology: https://510kreport.com/methodology