# K071189: Cordis Aviator Plus Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Cordis Europa, N.V.
- Decided: May 16, 2007 after 16 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 5 generations back to K001134 (2000). 12 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063563: Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation Catheter, Cordis Europa, N.V. (2007) Summary page 1.
- K050645: Cordis Amiia .014 Pta Balloon Catheter, Cordis Corp. (2005) Summary page 1.

## Most influential descendants
- K112797: Powerflex Pro Percutaneous Transluminal Angioplasty Catheter (2012), 10 descendants of its own
- K121442: Powerflex Pro Percutaneous Transluminal Angioplasty Catheter (2012), 9 descendants of its own
- K133843: Saber Percutaneous Transluminal Angioplasty Dilatation Catheter (2014), 6 descendants of its own
- K072798: Viatrac 14 Plus Peripheral Dilation Catheter (2008), 6 descendants of its own
- K151153: Pirouette 018 (2015), 4 descendants of its own

## Indications for use
The Cordis AVIATOR PLUS PTA Balloon Dilatation catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stems in the peripheral vasculature.

Source page: https://510kreport.com/device/K071189
Methodology: https://510kreport.com/methodology