Crosstella OTW
Crosstella OTW is an over-the-wire balloon catheter for peripheral angioplasty. Its distal balloon is inflated and deflated through an external device connected to the proximal manifold. A…
Crosstella OTW is an over-the-wire balloon catheter for peripheral angioplasty. Its distal balloon is inflated and deflated through an external device connected to the proximal manifold. A guidewire lumen runs through the inner tube to the manifold’s guidewire port.
It is intended for iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal stenoses, obstructive lesions of native or synthetic arteriovenous dialysis fistulas, and peripheral stent post-dilation. The system accepts guidewires up to 0.018 inches and 4 or 5 Fr introducer sheaths.
Listed Item
CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm).
Balloon and Working Lengths
Nominal balloon diameters range from 2 to 6 mm, with balloon lengths from 20 to 200 mm. Catheter working lengths are 900 or 1,500 mm. Radiopaque markers identify the balloon region; reinforcement tubing and strain relief are included in the shaft assembly.
5manufacturers in China registered for this device type
96catalogue 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) | K160004 |
| 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 |
| Over the counter | Yes |
| 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-F30150MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20080LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40020LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50100MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40120LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30120MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20060MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30060LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25040MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50200LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20120LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30080MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30040MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25080LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40200MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25020LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50020LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30150LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25040LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50040LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25150MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60150LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25060LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60060MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50020MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30120LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50150MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60040MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40120MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60200MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20080MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25150LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20200LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40100LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60040LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50120MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50200MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20060LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60020LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25200MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60150MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30060MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40020MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25100LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60080LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60200LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25020MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40150MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25120MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25200LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60080MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40040MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50080MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50040MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20040LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50100LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30200MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30100MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25080MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25120LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40100MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20200MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60100LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50120LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60100MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30020MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40080MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50060MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40150LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30200LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20150LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40060MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20020LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60020MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30040LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30020LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20120MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60060LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50080LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40060LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20100MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25060MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30100LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20020MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20100LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50150LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F30080LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20150MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40040LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40200LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60120MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F20040MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F40080LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F60120LW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F25100MW | Maximum Guidewire Diameter; 0.018 inch | In distribution |
| BD-F50060LW | 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.