# K102705: Armada 14 Pta Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular, Inc.
- Decided: Dec 7, 2010 after 78 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: 7 generations back to K001134 (2000). 25 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072798: Viatrac 14 Plus Peripheral Dilation Catheter, Abbott Vascular-Vascular Solutions (2008) Summary page 1.
- K050073: Modification to Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 1.
- K052791: Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 1.
- K083919: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2009) Summary page 1.

## Most influential descendants
- K260304: WAVE PTA Balloon Catheter (2026), 0 descendants of its own
- K252512: Armada™ 14 NC PTA Catheter (2026), 0 descendants of its own
- K151317: Armada 18 PTA Catheter (2015), 0 descendants of its own
- K121352: Armada 14XXT Pta Catheter (2012), 0 descendants of its own

## Indications for use
The device is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 to 4.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents up to 40 mm and self-expanding stents up to 80 mm in the vessels listed above.

Source page: https://510kreport.com/device/K102705
Methodology: https://510kreport.com/methodology