# K082579: Evercross .035 Otw Pta Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ev3, Inc.
- Decided: Nov 20, 2008 after 76 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: 5 generations back to K001134 (2000). 13 ancestors in all.
35 later devices descend from it; 6 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053116: Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx, Boston Scientific Corp (2005) Summary page 1.
- K062809: Admiral Xtreme Pta Catheter, Invatec Innovative Technologies (2006) Summary page 1.
- K072947: Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters, ClearStream Technologies, Ltd. (2008) Summary page 1.
- K072283: Dorado Pta Balloon Dilatation Catheter, Bard Peripheral Vascular, Inc. (2007) 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
- 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

## 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/K082579
Methodology: https://510kreport.com/methodology