Angioplasty balloons
R2P Metacross RX
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Find similar PTA balloons
Where to buy R2P Metacross RX
We do not have contact details for Kaneka Corporation yet. Send a request and we will route it to the right person for your country.
R2P Metacross RX models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| BD-P30020ER | — | Not stated | Available |
| BD-P30040ER | — | Not stated | Available |
| BD-P30060ER | — | Not stated | Available |
| BD-P30080ER | — | Not stated | Available |
| BD-P30100ER | — | Not stated | Available |
| BD-P30120ER | — | Not stated | Available |
| BD-P30150ER | — | Not stated | Available |
| BD-P30200ER | — | Not stated | Available |
| BD-P40020ER | — | Not stated | Available |
| BD-P40040ER | — | Not stated | Available |
| BD-P40060ER | — | Not stated | Available |
| BD-P40080ER | — | Not stated | Available |
| BD-P40100ER | — | Not stated | Available |
| BD-P40120ER | — | Not stated | Available |
| BD-P40150ER | — | Not stated | Available |
| BD-P40200ER | — | Not stated | Available |
| BD-P50020ER | — | Not stated | Available |
| BD-P50040ER | — | Not stated | Available |
| BD-P50060ER | — | Not stated | Available |
| BD-P50080ER | — | Not stated | Available |
| BD-P50100ER | — | Not stated | Available |
| BD-P50120ER | — | Not stated | Available |
| BD-P50150ER | — | Not stated | Available |
| BD-P50200ER | — | Not stated | Available |
| BD-P60020ER | — | Not stated | Available |
| BD-P60040ER | — | Not stated | Available |
| BD-P60060ER | — | Not stated | Available |
| BD-P60080ER | — | Not stated | Available |
| BD-P60100ER | — | Not stated | Available |
| BD-P60120ER | — | Not stated | Available |
| BD-P60150ER | — | Not stated | Available |
| BD-P60200ER | — | Not stated | Available |
| BD-P70020ER | — | Not stated | Available |
| BD-P70040ER | — | Not stated | Available |
| BD-P70060ER | — | Not stated | Available |
| BD-P70080ER | — | Not stated | Available |
| BD-P70100ER | — | Not stated | Available |
| BD-P70120ER | — | Not stated | Available |
| BD-P70150ER | — | Not stated | Available |
| BD-P70200ER | — | Not stated | Available |
| BD-P80020ER | — | Not stated | Available |
| BD-P80040ER | — | Not stated | Available |
| BD-P80060ER | — | Not stated | Available |
| BD-P80080ER | — | Not stated | Available |
FDA clearances
- 510(k) K163479 January 2017
Procedures that use angioplasty balloons
Frequently asked questions
What is R2P Metacross RX used for?
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Who makes R2P Metacross RX?
R2P Metacross RX is made by Kaneka Corporation. It is listed under peripheral angioplasty balloons in our device library.
What sizes does R2P Metacross RX come in?
The FDA device database does not list sizes for R2P Metacross RX. Check the instructions for use or ask a Kaneka Corporation representative.
Is R2P Metacross RX MRI safe?
The FDA device database entry for R2P Metacross RX does not state its MRI safety status. Check the labeling before MRI.
Is R2P Metacross RX FDA cleared?
R2P Metacross RX is covered by FDA submission K163479.
How do I contact a Kaneka Corporation sales representative?
Kaneka Corporation has not listed representatives on LA Vascular yet. Visit the Kaneka Corporation company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.