# K093286: Powercross .018 Otw Pta Dilation Catheter

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Nov 13, 2009 after 24 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001134 (2000). 16 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090849: Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090, AB14W020210150, Ev3, Inc. (2009) Summary page 1.
- K082579: Evercross .035 Otw Pta Dilatation Catheter, Ev3, Inc. (2008) Summary page 1.

## Most influential descendants
- K123544: Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter (2013), 8 descendants of its own
- K130911: Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter (2013), 7 descendants of its own
- K132777: Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation Catheter (2013), 6 descendants of its own
- K141118: Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter (2014), 5 descendants of its own
- K160004: Crosstella OTW (2016), 2 descendants of its own

## Recalls of this device
- Nov 10, 2016 · Class II · Z-0892-2017: Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturin
- Mar 29, 2016 · Class II · Z-1552-2016: Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the 

## Indications for use
The PowerCross .018" OTW PTA Dilatation 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. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Source page: https://510kreport.com/device/K093286
Methodology: https://510kreport.com/methodology