# K083919: Amphirion Deep 0.014 Otw Pta Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Invatec Innovative Technologies, S.R.L.
- Decided: Mar 13, 2009 after 72 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
Longest line of descent: 2 generations back to K042537 (2004). 5 ancestors in all.
26 later devices descend from it; 5 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)
- K042624: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 1.
- K050073: Modification to Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 1.
- K052791: Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 1.
- K072947: Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters, ClearStream Technologies, Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K102705: Armada 14 Pta Catheter (2010), 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 AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters, with 150 mm and 210 mm balloon lengths, are intended to dilate stenoses in the femoral, popliteal, and infra-popliteal arteries.

Source page: https://510kreport.com/device/K083919
Methodology: https://510kreport.com/methodology