# K122940: Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Mar 19, 2013 after 176 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: 1 generation back to K090822 (2009). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090822: Advance 14RX Rapid Exchange Pta Balloon Catheter, Cook, Inc. (2009) Summary page 1.

## Most influential descendants
- K152934: MMS PTA Balloon Catheter (2016), 0 descendants of its own
- K140593: Advance Salivary Balloon Catheter with Wire Guide (2014), 0 descendants of its own

## Indications for use
The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including internal pudendal, iliac, renal, popliteal, femoral, iliofemoral, anterior tibial, posterior tibial, peroneal, pedal, radial, brachial, and ulnar, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary arteries.

Source page: https://510kreport.com/device/K122940
Methodology: https://510kreport.com/methodology