# K020161: Agiltrac .018 Peripheral Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Feb 22, 2002 after 36 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.
No later device cites it as a predicate yet.
0 of 1 device 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) OTW VIATRAC™ 18 Peripheral Dilatation Catheter: named in the summary without a submission number

## Indications for use
The AGILTRAC™ 018 Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K020161
Methodology: https://510kreport.com/methodology