# K023504: Modification to Atb All-Terrain Balloon Pta Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Nov 13, 2002 after 26 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 no predicate by number.

## Most influential descendants
- K033875: Atb All-Terrain Balloon Pta Dilatation Catheter (2004), 1 descendant of its own
- K113300: Atb Advance Pta Dilatation Catheter (2011), 0 descendants of its own

## Recalls of this device
- Mar 17, 2016 · Class II · Z-1651-2016: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depre

## 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.

Source page: https://510kreport.com/device/K023504
Methodology: https://510kreport.com/methodology