# K190753: EverCrossTM 0.035 OTW PTA Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)
- Decided: Apr 23, 2019 after 29 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: 7 generations back to K001134 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110319: Evercross 0.035 Otw Pta Dilatation Catheter, Ev3, Inc. (2011) Summary page 4.

## Indications for use
The EverCross 0.889 mm (0.035 in) 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/K190753
Methodology: https://510kreport.com/methodology