Metacross OTW
Metacross OTW is an over-the-wire balloon catheter for peripheral angioplasty. A distal balloon inflates and deflates through an external inflation device connected to the proximal…
Metacross OTW is an over-the-wire balloon catheter for peripheral angioplasty. A distal balloon inflates and deflates through an external inflation device connected to the proximal manifold. A guidewire lumen extends through the shaft to a guidewire port at the manifold.
Indications include dilation of iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal stenoses, plus obstructive lesions of native or synthetic arteriovenous dialysis fistulas. It is also indicated for post-dilation of stents in the peripheral vasculature.
Listed Item
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
Dimensions and Compatibility
The catheter accepts guidewires up to 0.035 inches and is compatible with 5, 6 or 7 Fr sheaths or sheathless guiding catheters. Balloon diameters range from 3 to 12 mm and working lengths from 20 to 200 mm. Catheter working lengths are 650, 900 or 1,350 mm; radiopaque markers aid balloon positioning.
5manufacturers in China registered for this device type
162catalogue 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) | K152080 |
| 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-L40100MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40080SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40020SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50060MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80020SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40020CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90020CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30040SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40150CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60200MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2040MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60120MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50120CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90060CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60060MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50100CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70200MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60120SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40150MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70020SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60040SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60020MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30150CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60150SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70150CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0060CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60020SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80060SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40100SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80080SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80040MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90020MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40150SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90040SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70080MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30100CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50040CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0060SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2020SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2020MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60020CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60120CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40200MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60060SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50200SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50040MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70040SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0020CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30100MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2020CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30020SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40120CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30120MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50080SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0020SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60200CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90020SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30150MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70120CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50150SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50120MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90060MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30200SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60150MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30080MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50100MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80040SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70120MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0040SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90080CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90080SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70080CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70120SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0040MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80080MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70100SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0080SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80040CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40120SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30120CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70100CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70060MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60200SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50150CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40200SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70060SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40040MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0060MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40200CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30020MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60100MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0080CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60060CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80060CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60080MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30060MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50060SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50020MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80080CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50080CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80020MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70040MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60040MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60040CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50200MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60080CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2040CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70200SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40100CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40040CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0080MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90040MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60100CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70060CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0020MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70040CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30100SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90040CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30020CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70020CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30080SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50020CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30060CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40080CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50120SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40060SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30080CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70200CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70080SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70150SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30120SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40020MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50150MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90080MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50200CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70020MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L90060SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60080SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80020CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30060SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30150SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40120MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70100MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50080MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L70150MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60100SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40060CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50020SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30200CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L60150CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30200MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50100SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40080MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40060MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50060CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30040CW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L50040SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX2040SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L80060MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L40040SW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-L30040MW | Maximum Guidewire Diameter; 0.035 inch | In distribution |
| BD-LX0040CW | 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.