# K151317: Armada 18 PTA Catheter

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: Jul 6, 2015 after 49 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: 8 generations back to K001134 (2000). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102705: Armada 14 Pta Catheter, Abbott Vascular, Inc. (2010) Summary page 4.

## Indications for use
The Armada 18 is indicated to dilate stenosis in femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the device is also indicated for post-dilatation of balloon-expandable and self-expanding stents.

Source page: https://510kreport.com/device/K151317
Methodology: https://510kreport.com/methodology