# K110319: Evercross 0.035 Otw Pta Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Apr 14, 2011 after 70 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001134 (2000). 15 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082579: Evercross .035 Otw Pta Dilatation Catheter, Ev3, Inc. (2008) Summary page 1.
- K103322: Evercross 0.035 Otw Pta Dilation Catheter, Ev3, Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- K111899: Armada 35/35LL Pta Catheter (2011), 0 descendants of its own

## Indications for use
The EverCross 0.035" 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/K110319
Methodology: https://510kreport.com/methodology