# K022738: Agiltrac .035 Peripheral Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Sep 13, 2002 after 25 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 its predicate without a number.
- (no number) AGILTRAC .018 Peripheral Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K141354: Navajo Pta Balloon Dilatation Catheter (2015), 0 descendants of its own

## Indications for use
The AGILTRACTM,035 Peripheral Dilatation Catheter is indicated for the 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/K022738
Methodology: https://510kreport.com/methodology