# K042624: Amphirion Deep 0.014 Otw Pta Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Invatec Innovative Technologies, S.R.L.
- Decided: Jan 10, 2005 after 105 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.
99 later devices descend from it; 5 cite it directly.
0 of 100 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) Boston Scientific SYMMIETRY Small Vessel Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) Cordis AVIATOR Peripheral Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K063657: Vascutrak Pta Dilation Catheter (2006), 52 descendants of its own
- K073025: Vascutrak II Pta Dilatation Catheter (2007), 48 descendants of its own
- K082343: Vascutrak 2, Models: V14 and V18 (2008), 47 descendants of its own
- K103459: Vascutrak Pta Dilatation Catheter (2010), 36 descendants of its own
- K100303: Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-Xxyy (2010), 32 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 AMPHIRION™ 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/K042624
Methodology: https://510kreport.com/methodology