R2P Metacross RX
R2P Metacross RX is a rapid-exchange balloon catheter for peripheral angioplasty. Its 2000 mm working shaft has a 1.25 mm proximal-tube outer diameter and carries a distal balloon with…
R2P Metacross RX is a rapid-exchange balloon catheter for peripheral angioplasty. Its 2000 mm working shaft has a 1.25 mm proximal-tube outer diameter and carries a distal balloon with radiopaque markers.
An inflation device connected at the hub inflates and deflates the balloon. A distal guidewire lumen exits through the rapid-exchange port, accommodating a guidewire up to 0.035 inch. Compatible sheath introducers have a minimum diameter of 6 French.
Listed Item
R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
Balloon and Position Markers
Balloon options span 3 to 8 mm in nominal inflated diameter and 20 to 200 mm in working length. The shaft has three position markers, located 900, 1200 and 1500 mm from the distal tip. The family includes different balloon dimensions within this single catheter working length.
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Kossel Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Kaneka Corporation, Japan |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K163479 |
| Record published | 2017-06-01 |
| Record revised | 2019-08-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BD-P70080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P30200ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P70100ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P60120ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P60200ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P50060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P60060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P40200ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P60150ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P40040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P30150ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P60040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P40060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P70120ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P40100ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P70200ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P80040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P80020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P40020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P70150ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P50120ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P70060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P40150ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P30040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P70040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P30100ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P50040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P30080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P80060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P50080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P70020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P60080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P40080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P50200ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P30060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P40120ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P60100ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P60020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P50100ER | Compatible Sheath Diameter; 6 Fr | In distribution |
| BD-P30020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P30120ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P50150ER | Balloon Length; 150 mm | In distribution |
| BD-P80080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-P50020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Parafleet SC 018 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 1,460 |
| Jade Plus PTA Balloon Dilatation Catheter / Jade Plus 18 OTW | OrbusNeich Medical (Shenzhen) Co., Ltd. | 832 |
| Jade PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 667 |
| Parafleet SC 014 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 572 |
| Minerva PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 504 |
| Advocate | Arravasc, Ltd. | 441 |
| Ultraverse® 035 PTA Dilatation Catheter | Bard Peripheral Vascular, Inc. | 361 |
| Polux PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 359 |
| Advance | Cook Incorporated | 355 |
| Pacific™ Plus | Medtronic, Inc. | 347 |
| EverCross™ | ev3, Inc. | 316 |
| Achilles NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 297 |
Showing 12 of 167. All products under Catheter, Angioplasty, Peripheral, Transluminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163479 | 2017-01-11 |
| K160013 | 2016-04-29 |
| K160004 | 2016-04-29 |
| K152873 | 2016-01-22 |
| K152887 | 2016-01-22 |
| K152080 | 2015-09-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.