# K160013: Crosperio OTW

- Pathway: 510(k) (Traditional)
- Applicant: KANEKA Corporation
- Decided: Apr 29, 2016 after 116 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). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131199: Ultraverse RX Pta Balloon Dilatation Catheter, Bard Peripheral Vascular, Inc. (2013) Summary page 6.
- K152080: Metacross OTW PTA Balloon Dilatation Catheter, KANEKA Corporation (2015) Summary page 6.

## Indications for use
The Crosperio OTW PTA Balloon Dilatation Catheter is intended to dilate stenosis 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/K160013
Methodology: https://510kreport.com/methodology