# K121352: Armada 14XXT Pta Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular
- Decided: Aug 15, 2012 after 103 days
- Product code: DQY (Catheter, Percutaneous)
- 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 1.

## Cited in the summary but kept off the family tree
- K103011: Ulticare Safety Insulin Syringe, Ulti-Med Intl., Inc. (2011). Our reading of the summary gave K103011, FDA’s number for Ulticare Safety Insulin Syringe (Ulti-Med Intl., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Abbott Vascular TREK OTW Coronary Dilatation Catheter”. Kept off the family tree. Summary page 1.
- K110617: Mini Trek RX 1.20 MM Coronary Dilatation Catheter, Mini Trek Otw 1.20 MM Coronary Dilatation Catheter, Abbott Vascular (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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 5.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents.

Source page: https://510kreport.com/device/K121352
Methodology: https://510kreport.com/methodology