# K050073: Modification to Amphirion Deep 0.014 Otw Pta Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Invatec Innovative Technologies, S.R.L.
- Decided: Feb 11, 2005 after 30 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) currently marketed PTA balloon catheter: named in the summary without a submission number

## Most influential descendants
- K083919: Amphirion Deep 0.014 Otw Pta Balloon Catheter (2009), 26 descendants of its own
- K103464: Pacific Xtreme Ptca Balloon Dilatation Catheter (2010), 9 descendants of its own
- K133843: Saber Percutaneous Transluminal Angioplasty Dilatation Catheter (2014), 6 descendants of its own
- K102645: Willow/Elm Pta Balloon Dilatation Catheter (2010), 6 descendants of its own
- K151153: Pirouette 018 (2015), 4 descendants of its own

## Recalls of this device
- Oct 23, 2015 · Class II · Z-0243-2016: Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.

## Indications for use
The AMPHIRIONTM DEEP 0.014" OTW PTA Balloon Catheter is intended to dilate stenoses in the 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/K050073
Methodology: https://510kreport.com/methodology