# K090849: Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090, AB14W020210150

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: May 1, 2009 after 32 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: 1 generation back to K082854 (2008). 1 ancestor in all.
25 later devices descend from it; 9 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082854: Nanocorss .014 Otw Pta Dilatation Catheter, Ev3, Inc. (2008) Summary page 1.

## Most influential descendants
- K093286: Powercross .018 Otw Pta Dilation Catheter (2009), 14 descendants of its own
- K123544: Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter (2013), 8 descendants of its own
- K101062: Glider Pta Balloon Catheter (2010), 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

## Recalls of this device
- Nov 12, 2010 · Not classified · Z-0789-2011: ev3 has determined that specific lots of the NanoCross .014 OTW PTA Dilatation catheters may crack or break during use. Cracking or breaking of the catheter shaft can result in the inability to inflat

## Indications for use
The NanoCross 0.014" 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.

Source page: https://510kreport.com/device/K090849
Methodology: https://510kreport.com/methodology