Crosperio OTW
Crosperio OTW is an over-the-wire balloon catheter for peripheral angioplasty and post-dilatation of peripheral stents. The distal balloon expands through fluid delivered from a connected…
Crosperio OTW is an over-the-wire balloon catheter for peripheral angioplasty and post-dilatation of peripheral stents. The distal balloon expands through fluid delivered from a connected inflation device.
A full-length guidewire pathway runs from the distal tip to the proximal manifold. It accommodates a guidewire up to 0.014 inches, while a separate inflation pathway serves the balloon.
Listed Item
CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
Access and Sizes
The catheter is compatible with a 4 Fr introducer sheath. Balloon diameters range from 1.5 to 4.0 mm and working lengths from 20 to 200 mm, with catheter working lengths of 65, 90 or 150 cm. Applications include selected peripheral arteries and obstructed native or synthetic dialysis fistulae.
5manufacturers in China registered for this device type
87catalogue 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) | K160013 |
| 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. |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BD-B35200MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25080LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35150SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25150LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40080LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25040SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20120MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40150LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15020MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25120LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25200MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15120MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25150SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40200LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40150MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40120SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15020SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35120LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40200SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20040MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25200SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30150SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35120MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30150LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20080MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40080MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30150MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40200MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35150MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40120LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20200SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25080MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40080SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25040MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30120MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35200SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30040LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30040SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25120SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15040LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40040LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25150MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25120MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30080SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20040SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35120SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20200LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15080MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20080LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35150LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30080MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30200LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15040SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35040MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30040MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25080SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35080LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20080SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35040LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30120SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25040LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15120SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20120SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35080SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20200MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20150LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40150SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30120LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35200LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35080MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30200SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15080SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20150MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15120LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15080LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B25200LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40040MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30200MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40120MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20150SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15040MW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B40040SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20120LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B15020LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B20040LW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B35040SW | Maximum Guidewire Diameter; 0.014 inch | In distribution |
| BD-B30080LW | Maximum Guidewire Diameter; 0.014 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.