# K173515: Admiral Xtreme

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Apr 12, 2018 after 149 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: 3 generations back to K042538 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062809: Admiral Xtreme Pta Catheter, Invatec Innovative Technologies (2006) Summary page 5.
- K100921: Admiral Xtreme Pta Balloon Dilatation Catheter, Invatec S.P.A. (2010) Summary page 5.

## Indications for use
The Admiral Xtreme PTA balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K173515
Methodology: https://510kreport.com/methodology