# K013581: Cordis Aviator Peripheral Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Cordis, A Johnson & Johnson Co.
- Decided: Nov 28, 2001 after 30 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: 1 generation back to K971448 (1997). 5 ancestors in all.
65 later devices descend from it; 4 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971448: Cordis Opta LP Pta Balloon Catheter, Cordis Corp. (1997) Summary page 1.
- K981407: Opta LP Pta Balloon Catheter/Powerflex Plus Pta Balloon Catheter, Cordis Corp. (1998) Summary page 1.
- K003159: Cordis Slalom Pta Balloon Catheter, Cordis Corp. (2000) Summary page 1.
- K003920: Cordis M3 Pta Dilatation Catheter, Cordis Corp. (2001) Summary page 1.
- K010831: Aviator Peripheral Dilatation Catheter, Guidant Corp. (2001)

## Most influential descendants
- K050629: Angiosculpt Scoring Balloon Catheter (2005), 38 descendants of its own
- K072225: Angiosculpt Pta Scoring Balloon Catheter (2007), 37 descendants of its own
- K080151: Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 (2008), 36 descendants of its own
- K082059: Angiosculpt Pta Scoring Balloon Catheter (2008), 34 descendants of its own
- K081220: Modification to Angiosculpt Pta Scoring Balloon Catheter (2008), 34 descendants of its own

## Indications for use
The Cordis AVIATOR Peripheral Dilatation catheter is intended to dilate stenoses in the 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/K013581
Methodology: https://510kreport.com/methodology