# K121265: Amphirion Plus Pta Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: May 22, 2012 after 26 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: 3 generations back to K042538 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052791: Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 2.
- K092361: Reef HP 0.035 Otw Pta Balloon Dilatation Catheter, Invatec S.P.A. (2009) Summary page 2.
- K042537: Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx, Invatec Innovative Technologies (2004) Summary page 2.

## Indications for use
The Amphirion Tm Plus PTA Catheter is intended to dilate stemosis in the iliac, femnoral, ilio-fernoral, popliteal, infra-popliteal. and renal arteries and for the treatment of obstructive lesions of native or synthetic arteuiovenoujs dialysis fistulae.

Source page: https://510kreport.com/device/K121265
Methodology: https://510kreport.com/methodology