# K163479: R2P Metacross RX

- Pathway: 510(k) (Special)
- Applicant: KANEKA Corporation
- Decided: Jan 11, 2017 after 30 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)
- K150865: Metacross RX PTA Balloon Dilitation Catheter, KANEKA Corporation (2015) Summary page 5.

## Indications for use
The R2P 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/K163479
Methodology: https://510kreport.com/methodology