# K160004: Crosstella 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). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093286: Powercross .018 Otw Pta Dilation Catheter, Ev3, Inc. (2009) Summary page 6.

## Most influential descendants
- K240653: SmartCardia 7L Platform (MCT) (2024), 1 descendant of its own
- K243349: BodyGuardian Remote Monitoring System (BGRMS v3.0) (2026), 0 descendants of its own

## Indications for use
The Crosstella 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/K160004
Methodology: https://510kreport.com/methodology