# K052036: Atb Advance Pta Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Aug 25, 2005 after 28 days
- Product code: DQY (Catheter, Percutaneous)
- 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
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K090364: Extra Pta Balloon Catheter with Embolic Protection Feature (2010), 10 descendants of its own
- K111750: Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter with Embolic Capture Feature (2011), 5 descendants of its own
- K111010: Spiderfx Embolic Protection Device (2011), 4 descendants of its own
- K120805: Proteus Pta Balloon Catheter with Embolic Capture Feature (2012), 3 descendants of its own
- K180023: Wirion (2018), 2 descendants of its own

## Recalls of this device
- Feb 28, 2007 · Not classified · Z-0665-2007: Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.

## Indications for use
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance PTA Dilatation Catheter is also intended for post-dilatation of balloon-expandable peripheral vascular stents.

Source page: https://510kreport.com/device/K052036
Methodology: https://510kreport.com/methodology