# K023320: Agiltrac .035 Peripheral Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Dec 10, 2002 after 67 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.
60 later devices descend from it; 2 cite it directly.
1 of 61 devices in its family (counting itself) has 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) Ancure Iliac Balloon Catheter: named in the summary without a submission number

## Most influential descendants
- K032587: Edwards Peripheral Dilatation Catheter (2003), 48 descendants of its own
- K052149: Edwards Peripheral Dilation Catheter (2005), 47 descendants of its own
- K083657: Conquest Pta Balloon Dilatation Catheter (2008), 44 descendants of its own
- K103459: Vascutrak Pta Dilatation Catheter (2010), 36 descendants of its own
- K112182: Angiosculpt Pta Scoring Balloon Catheter (2011), 29 descendants of its own

## Indications for use
The AGILTRACTM.035 Periheral Dilatation Catheter is intended to: dilate stenoses in peripheral arteries treat obstructive lesions of native or synthetic A-V fistulae secure the attachment systems in the iliac arteries, and to expand vascular prosthesis limbs

Source page: https://510kreport.com/device/K023320
Methodology: https://510kreport.com/methodology