# K050645: Cordis Amiia .014 Pta Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Apr 1, 2005 after 18 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: 2 generations back to K971448 (1997). 6 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013581: Cordis Aviator Peripheral Dilatation Catheter, Cordis, A Johnson & Johnson Co. (2001) Summary page 1.
- K003920: Cordis M3 Pta Dilatation Catheter, Cordis Corp. (2001) Summary page 1.

## Most influential descendants
- K063563: Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation Catheter (2007), 24 descendants of its own
- 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

## Indications for use
The Cordis AMIIA PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K050645
Methodology: https://510kreport.com/methodology