# K063563: Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Europa, N.V.
- Decided: Mar 7, 2007 after 99 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: 4 generations back to K001134 (2000). 11 ancestors in all.
24 later devices descend from it; 1 cites 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)
- K050645: Cordis Amiia .014 Pta Balloon Catheter, Cordis Corp. (2005) Summary page 2.
- K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx, Boston Scientific Corp (2005) Summary page 2.

## Most influential descendants
- K071189: Cordis Aviator Plus Pta Balloon Dilatation Catheter (2007), 23 descendants of its own
- 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

## Indications for use
The Cordis AMIIA PTA Balloon Dilatation catheter is intended 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 stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K063563
Methodology: https://510kreport.com/methodology