Metacross RX
Metacross RX is a rapid-exchange balloon catheter for peripheral angioplasty, including dilation of arterial stenoses and obstructed dialysis fistulae. A distal balloon expands through an…
Metacross RX is a rapid-exchange balloon catheter for peripheral angioplasty, including dilation of arterial stenoses and obstructed dialysis fistulae. A distal balloon expands through an inflation lumen connected to the proximal hub.
Its guidewire lumen runs through the distal portion and opens at a rapid-exchange port. Radiopaque markers help identify the balloon position. The catheter assembly includes distal and proximal tubes, a guidewire transition tube and strain relief.
Listed Item
METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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 Shaft Configurations
The family accepts guidewires up to 0.035 inch and is compatible with 6 or 7 French sheathless guiding catheters and sheaths. Balloon diameters span 3 to 12 mm and balloon working lengths span 20 to 200 mm. Catheter working lengths are 900, 1350 or 2000 mm, depending on configuration.
14manufacturers in China registered for this device type
162catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous
Record
| Listed by | Kaneka Corporation, Japan |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K150865 |
| Record published | 2016-08-26 |
| 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-L70020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30120CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0080CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70120CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70200CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40150MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80080CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60150MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70120ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70200MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40150CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50080CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60020MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50120CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30080MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0040MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50150MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40060CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40200ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40080CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60060MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50060CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40080MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50080MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30100CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40020CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80040MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30060MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30150CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30100ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30150MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50100CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30060CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0060MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60150CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70100ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50020CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90040MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90060CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30120ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70040CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50060MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60200CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60150ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90040CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40200CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60100ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70120MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50200ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70040MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90080CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80020MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40060MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50150ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60120ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60100CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30040CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30020MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40100CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30100MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60120CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80060MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40100ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80080MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50120MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40100MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30080CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90080MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0040CR | Distal Shaft Diameter; 5.7 Fr | In distribution |
| BD-L30020CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60080CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50150CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30150ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50100MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0020CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40120CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60200MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0080MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50040CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50200CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70200ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70080MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60060CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0060CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80060CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60040CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40120ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30200ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70020MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90060MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90020CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40040CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50020MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90020MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70060CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60120MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50040MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60080MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40120MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40040MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70080CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2020CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40150ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50200MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2040CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60200ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2040MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30120MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70150CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0020MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2020MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30200MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50100ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40020MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80060ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50120ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70020CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70150MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70100CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60020CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30200CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70060MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30040MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80020ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70150ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40080ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40200MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80040CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80020CR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70100MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60100MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60040MR | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50040ER | Maximum Guidewire Diameter; 0.035 inch | In distribution |
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| Sherpa NX Active | Medtronic, Inc. | 571 |
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Showing 12 of 500. All products under Catheter, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150865 | 2015-08-03 |
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.