# K103322: Evercross 0.035 Otw Pta Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ev3, Inc.
- Decided: Dec 6, 2010 after 24 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K110319: Evercross 0.035 Otw Pta Dilatation Catheter (2011), 5 descendants of its own
- K151141: Cronus HP - High Pressure Peripheral Balloon Catheter (2016), 1 descendant of its own
- K190037: Cronus HP PTA Balloon Catheter (2019), 0 descendants of its own
- K190753: EverCrossTM 0.035 OTW PTA Dilatation Catheter (2019), 0 descendants of its own
- K142654: Fortrex 0.035 OTW PTA Balloon Catheter (2014), 0 descendants of its own

## Recalls of this device
- Apr 9, 2014 · Class II · Z-1489-2014: Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length p

Source page: https://510kreport.com/device/K103322
Methodology: https://510kreport.com/methodology