# K113681: Gladiator Pta Balloon Dilation Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Jan 11, 2012 after 27 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.
2 later devices descend from it; 1 cites it directly.
0 of 14 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 2.

## Most influential descendants
- K132810: Gladiator Elite Pta Balloon Dilatation Catheter (2014), 1 descendant of its own
- K141597: Mustang Balloon Dialation Catheter (2014), 0 descendants of its own

## Indications for use
The Gladiator 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. The Gladiator 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/K113681
Methodology: https://510kreport.com/methodology