# K113300: Atb Advance Pta Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Dec 9, 2011 after 30 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 3 generations back to K970299 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033875: Atb All-Terrain Balloon Pta Dilatation Catheter, Cook, Inc. (2004) Summary page 1.
- K052036: Atb Advance Pta Dilatation Catheter, Cook, Inc. (2005) Summary page 1.
- K063252: Atb Advanced Pta Dilatation Catheter, Cook, Inc. (2006) Summary page 1.

## 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. The AIB Advance® PTA Dilatation Catheter (ATB) is also intended for post dilatation of balloon-expandable peripheral vascular stents.

Source page: https://510kreport.com/device/K113300
Methodology: https://510kreport.com/methodology