Crosstella RX
Crosstella RX is a rapid-exchange balloon catheter for peripheral angioplasty. Its distal balloon inflates and deflates through an inflation device attached to the proximal hub, while…
Crosstella RX is a rapid-exchange balloon catheter for peripheral angioplasty. Its distal balloon inflates and deflates through an inflation device attached to the proximal hub, while radiopaque markers help identify the balloon’s position.
A guidewire passes through the distal guidewire-transition lumen and exits through a port on the catheter shaft. The catheter accepts guidewires up to 0.018 inches and is used with the specified 4 or 5 Fr introducer sheath.
Listed Item
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
Balloon and Catheter Options
The range includes nominal balloon diameters from 2 to 6 mm and working lengths from 20 to 200 mm, with catheter working lengths of 900, 1,500 or 2,000 mm. A supplied flushing needle is used to flush and fill the guidewire lumen before use.
5manufacturers in China registered for this device type
144catalogue numbers in this listing
6510(k) clearances naming this product code
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) | K152873 |
| 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-F60100MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60020LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30060MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20150MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60150ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40040LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50020ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30200ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30080ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40100LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25150ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25060MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40120MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30040ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40020LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30200LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25150MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25060LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25150LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20020MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30150MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25200ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20150ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40100ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20040ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30150ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50060ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20020ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60100ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60200LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40200MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40120LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60060MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30200MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40200LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30080MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50120MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30020ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25080ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60080LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40080ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20080MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50060MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40150MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25020LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20150LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25080LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30150LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20060LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25040MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40120ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60120ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25020ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60120LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40060ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30100ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40080MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25200LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60150MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60120MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60200ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50020MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50100LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30040LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50100ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25120ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50100MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20100MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60040ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40100MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30060ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25020MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25120LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40020MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40150LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40200ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30060LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60040LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50080MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40020ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20120ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50040MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20020LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20200LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25040ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20080LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25120MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40060LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30120LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20040LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50120LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50020LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20120MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50080LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50120ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50040LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50150LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25200MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25040LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50080ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30020MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50150MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40080LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50200LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25100ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50040ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60020ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30080LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30120ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60020MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40040MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50200ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30020LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25080MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20200MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20080ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40040ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20040MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20100ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40060MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60040MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50060LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30100LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20100LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30120MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20200ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60100LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40150ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60060LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30100MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60150LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25060ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50200MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60060ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30040MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20060ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60080MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25100MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25100LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20120LR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60080ER | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20060MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60200MR | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50150ER | Maximum Guidewire Diameter; 0.018 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.