# K033875: Atb All-Terrain Balloon Pta Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Apr 2, 2004 after 109 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: 2 generations back to K970299 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022552: Atb All-Terrain Balloon Pta Dilatation Catheter, Cook, Inc. (2002) Summary page 1.
- K023504: Modification to Atb All-Terrain Balloon Pta Dilatation Catheter, Cook, Inc. (2002) Summary page 1.
- K031766: Atb All-Terrain Balloon Pta Dilatation Catheter, Cook, Inc. (2003) Summary page 1.
- K032931: Pta Balloon Catheter, Cook, Inc. (2003) Summary page 1.
- K983055: RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003, Guidant Corp. (1998) Summary page 1.

## Most influential descendants
- K113300: Atb Advance Pta Dilatation Catheter (2011), 0 descendants of its own

## 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 All-Terrain Balloon PTA Dilatation Catheter is also intended for post-dilatation of balloon-expandable peripheral vascular stents.

Source page: https://510kreport.com/device/K033875
Methodology: https://510kreport.com/methodology