# K090822: Advance 14RX Rapid Exchange Pta Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Apr 27, 2009 after 32 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
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PTA Balloon Catheter: named in the summary without a submission number

## Most influential descendants
- K123544: Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter (2013), 8 descendants of its own
- K130911: Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter (2013), 7 descendants of its own
- K132777: Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation Catheter (2013), 6 descendants of its own
- K141118: Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter (2014), 5 descendants of its own
- K122940: Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3 (2013), 2 descendants of its own

## Indications for use
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K090822
Methodology: https://510kreport.com/methodology