# K150865: Metacross RX PTA Balloon Dilitation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: KANEKA Corporation
- Decided: Aug 3, 2015 after 124 days
- Product code: DQY (Catheter, Percutaneous)
- 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). 18 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 23 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.
- K131199: Ultraverse RX Pta Balloon Dilatation Catheter, Bard Peripheral Vascular, Inc. (2013) Summary page 5.

## Most influential descendants
- K152873: Crosstella RX Balloon Dilatation Catheter (2016), 1 descendant of its own
- K201377: SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter (2020), 0 descendants of its own
- K163479: R2P Metacross RX (2017), 0 descendants of its own
- K152887: Crosperio RX PTA Balloon Dilatation Catheter (2016), 0 descendants of its own

## Indications for use
The Metacross RX 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/K150865
Methodology: https://510kreport.com/methodology