# K152080: Metacross OTW PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: KANEKA Corporation
- Decided: Sep 24, 2015 after 59 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). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 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 5.

## Most influential descendants
- K160013: Crosperio OTW (2016), 0 descendants of its own

## Indications for use
The Metacross OTW PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal 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/K152080
Methodology: https://510kreport.com/methodology