# K082854: Nanocorss .014 Otw Pta Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ev3, Inc.
- Decided: Dec 4, 2008 after 66 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.
26 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K090849: Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090, AB14W020210150 (2009), 25 descendants of its own
- 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

## 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

Source page: https://510kreport.com/device/K082854
Methodology: https://510kreport.com/methodology