# K103751: Mustang Balloon Dilatation Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Mar 22, 2011 after 89 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: 5 generations back to K001134 (2000). 10 ancestors in all.
15 later devices descend from it; 10 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993305: Transluminal Balloon Dilatation Catheter, Boston Scientific Corp (2000) Summary page 1.
- K072283: Dorado Pta Balloon Dilatation Catheter, Bard Peripheral Vascular, Inc. (2007) Summary page 1.

## Most influential descendants
- K113681: Gladiator Pta Balloon Dilation Catheter (2012), 2 descendants of its own
- K201170: Athletis PTA Balloon Dilatation Catheter (2020), 1 descendant of its own
- K160256: Polux , Minerva and Atropos PTA Balloon Dilatation Catheter (2016), 1 descendant of its own
- K132810: Gladiator Elite Pta Balloon Dilatation Catheter (2014), 1 descendant of its own
- K112697: Charger Pta Ballon Dilatation Catheter (2011), 1 descendant of its own

## Indications for use
The Mustang Tm Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries. The MustangTm 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/K103751
Methodology: https://510kreport.com/methodology