# K111899: Armada 35/35LL Pta Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular
- Decided: Oct 3, 2011 after 90 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001134 (2000). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110319: Evercross 0.035 Otw Pta Dilatation Catheter, Ev3, Inc. (2011)
- K100921: Admiral Xtreme Pta Balloon Dilatation Catheter, Invatec S.P.A. (2010) Summary page 1.
- K090509: Foxcross .035 Pta Catheter 14 MM X 20MM X 80 CM, Model 10342-20, Foxcross .035 Pta Catheter, Abbott Vascular-Vascular Solutions (2009) Summary page 1.

## Recalls of this device
- Aug 20, 2012 · Class II · Z-2450-2012: Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.

## Indications for use
The device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal, arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Source page: https://510kreport.com/device/K111899
Methodology: https://510kreport.com/methodology