# K252512: Armada™ 14 NC PTA Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Feb 13, 2026 after 186 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 5.

## Indications for use
The Armada™ 14 NC PTA Catheter is indicated to dilate stenosis in the peripheral vasculature, including femoral, infra-popliteal, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 mm to 6.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents, scaffolds (i.e., the Abbott Esprit™ BTK Everolimus Eluting Resorbable Scaffold System), and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K252512
Methodology: https://510kreport.com/methodology