Jade Plus PTA Balloon Dilatation Catheter / Jade Plus 18 OTW
Jade Plus is a family of over-the-wire balloon catheters for angioplasty in peripheral blood vessels. The catheter follows a guidewire to the treated region, where balloon inflation…
Jade Plus is a family of over-the-wire balloon catheters for angioplasty in peripheral blood vessels. The catheter follows a guidewire to the treated region, where balloon inflation provides the dilation used to widen a narrowed vessel segment.
The range includes configurations for standard 0.014, 0.018 and 0.035 inch guidewires. These wire sizes identify different catheter configurations rather than an interchangeable guidewire choice for every model.
Listed Item
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW
Peripheral Applications
The range covers peripheral arteries and obstructive lesions in native or synthetic arteriovenous dialysis fistulae. It is also intended for post-dilation of balloon-expandable or self-expanding peripheral stents, extending the balloon’s mechanical role to an already placed stent.
5manufacturers in China registered for this device type
832catalogue numbers in this listing
3510(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 | OrbusNeich Medical (Shenzhen) Co., Ltd., China |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K241025 |
| Record published | 2024-07-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5945-020-32 | In distribution | |
| 6070-180-12 | In distribution | |
| 5825-300-12 | In distribution | |
| 6040-180-22 | In distribution | |
| 5820-020-12 | In distribution | |
| 5825-015-22 | In distribution | |
| 5860-080-12 | In distribution | |
| 5930-150-12 | In distribution | |
| 5830-040-12 | In distribution | |
| 5855-120-32 | In distribution | |
| 5815-180-12 | In distribution | |
| 5820-020-32 | In distribution | |
| 5945-060-12 | In distribution | |
| 5825-020-32 | In distribution | |
| 60120-080-22 | In distribution | |
| 5955-060-22 | In distribution | |
| 5920-100-32 | In distribution | |
| 5970-100-32 | In distribution | |
| 5855-060-22 | In distribution | |
| 5840-015-12 | In distribution | |
| 5820-015-32 | In distribution | |
| 5930-150-22 | In distribution | |
| 5850-150-22 | In distribution | |
| 60120-080-12 | In distribution | |
| 5820-040-12 | In distribution | |
| 60120-060-12 | In distribution | |
| 6050-300-32 | In distribution | |
| 5930-020-32 | In distribution | |
| 5815-150-22 | In distribution | |
| 5845-240-32 | In distribution | |
| 5920-015-22 | In distribution | |
| 5945-120-32 | In distribution | |
| 5920-040-32 | In distribution | |
| 5925-020-22 | In distribution | |
| 5970-150-32 | In distribution | |
| 5930-240-22 | In distribution | |
| 5945-150-32 | In distribution | |
| 5935-060-32 | In distribution | |
| 5830-020-32 | In distribution | |
| 5945-240-32 | In distribution | |
| 6060-020-22 | In distribution | |
| 6060-080-32 | In distribution | |
| 5920-020-12 | In distribution | |
| 5945-150-22 | In distribution | |
| 60100-060-22 | In distribution | |
| 5855-120-12 | In distribution | |
| 5960-300-22 | In distribution | |
| 5935-300-12 | In distribution | |
| 6070-100-12 | In distribution | |
| 6050-300-12 | In distribution | |
| 5945-015-22 | In distribution | |
| 5850-015-32 | In distribution | |
| 5855-015-32 | In distribution | |
| 5930-020-12 | In distribution | |
| 5825-120-32 | In distribution | |
| 5955-120-32 | In distribution | |
| 5915-080-32 | In distribution | |
| 5915-240-32 | In distribution | |
| 5955-300-32 | In distribution | |
| 5945-150-12 | In distribution | |
| 5855-040-12 | In distribution | |
| 5860-020-12 | In distribution | |
| 5860-150-12 | In distribution | |
| 6030-020-22 | In distribution | |
| 6060-240-22 | In distribution | |
| 5945-180-12 | In distribution | |
| 5925-100-22 | In distribution | |
| 6070-150-12 | In distribution | |
| 5930-300-12 | In distribution | |
| 5820-040-32 | In distribution | |
| 5840-120-22 | In distribution | |
| 5815-240-32 | In distribution | |
| 5820-060-32 | In distribution | |
| 5960-080-22 | In distribution | |
| 5820-100-22 | In distribution | |
| 6050-060-22 | In distribution | |
| 5925-100-32 | In distribution | |
| 5850-015-12 | In distribution | |
| 5860-100-32 | In distribution | |
| 6070-100-22 | In distribution | |
| 5825-060-32 | In distribution | |
| 5830-300-32 | In distribution | |
| 6030-240-32 | In distribution | |
| 5935-180-12 | In distribution | |
| 5815-300-22 | In distribution | |
| 5830-120-12 | In distribution | |
| 5830-040-22 | In distribution | |
| 6050-040-22 | In distribution | |
| 5840-120-12 | In distribution | |
| 5830-150-22 | In distribution | |
| 5960-040-22 | In distribution | |
| 5850-060-32 | In distribution | |
| 5835-240-12 | In distribution | |
| 5855-100-22 | In distribution | |
| 5845-120-32 | In distribution | |
| 5945-020-12 | In distribution | |
| 6070-150-22 | In distribution | |
| 5950-080-12 | In distribution | |
| 5835-150-12 | In distribution | |
| 5825-180-22 | In distribution | |
| 5860-040-32 | In distribution | |
| 60100-040-12 | In distribution | |
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| 5940-240-22 | In distribution | |
| 5835-015-22 | In distribution | |
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| 5815-060-22 | In distribution | |
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| 5925-040-12 | In distribution | |
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| 6070-080-32 | In distribution | |
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| 5950-180-32 | In distribution | |
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| 5940-020-32 | In distribution | |
| 6040-180-32 | In distribution | |
| 5970-060-22 | In distribution | |
| 5855-080-12 | In distribution | |
| 5815-100-32 | In distribution | |
| 5955-300-12 | In distribution | |
| 5920-060-32 | In distribution | |
| 60120-020-22 | In distribution | |
| 5940-300-12 | In distribution | |
| 6050-180-22 | In distribution | |
| 5940-120-12 | In distribution | |
| 5955-120-12 | In distribution | |
| 5935-120-22 | In distribution | |
| 5820-080-22 | In distribution | |
| 5935-180-22 | In distribution | |
| 6060-300-12 | In distribution | |
| 5845-060-12 | In distribution | |
| 6070-180-22 | In distribution | |
| 5920-015-32 | In distribution | |
| 5850-040-22 | In distribution | |
| 5955-100-22 | In distribution | |
| 5830-015-22 | In distribution | |
| 6060-240-12 | In distribution | |
| 5935-120-12 | In distribution | |
| 5830-120-22 | In distribution | |
| 5920-300-22 | In distribution | |
| 5940-150-32 | In distribution | |
| 6070-080-12 | In distribution | |
| 6030-180-32 | In distribution | |
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| 5925-150-32 | In distribution | |
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| 5815-040-32 | In distribution | |
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| 5940-300-32 | In distribution | |
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| 5855-080-32 | In distribution | |
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| 6060-040-32 | In distribution | |
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| 5815-300-32 | In distribution | |
| 60100-080-12 | In distribution | |
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| 5915-180-22 | In distribution | |
| 5925-120-22 | In distribution | |
| 5915-060-12 | In distribution | |
| 5825-240-32 | In distribution | |
| 5935-015-32 | In distribution | |
| 5845-015-12 | In distribution | |
| 5835-120-12 | In distribution | |
| 5850-040-12 | In distribution | |
| 5815-040-22 | In distribution | |
| 5845-080-32 | In distribution | |
| 5860-180-12 | In distribution | |
| 5935-020-22 | In distribution | |
| 5860-150-22 | In distribution | |
| 5930-100-32 | In distribution | |
| 5920-240-22 | In distribution | |
| 5925-080-12 | In distribution | |
| 6050-020-32 | In distribution | |
| 5855-300-32 | In distribution | |
| 6050-100-12 | In distribution | |
| 5915-040-32 | In distribution | |
| 5960-180-22 | In distribution | |
| 5820-150-32 | In distribution | |
| 5855-120-22 | In distribution | |
| 5955-240-32 | In distribution | |
| 5830-015-12 | In distribution | |
| 5955-040-32 | In distribution | |
| 5850-060-22 | In distribution | |
| 5925-240-12 | In distribution | |
| 5855-020-22 | In distribution | |
| 5855-150-12 | In distribution | |
| 5930-040-22 | In distribution | |
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| 6050-060-32 | In distribution | |
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| 5950-150-32 | In distribution | |
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| 5935-240-12 | In distribution | |
| 5925-060-32 | In distribution | |
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| 5955-180-32 | In distribution | |
| 5925-015-32 | In distribution | |
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| 5845-150-32 | In distribution | |
| 5820-060-22 | In distribution | |
| 6050-020-22 | In distribution | |
| 6050-040-12 | In distribution | |
| 5860-060-22 | In distribution | |
| 5845-150-12 | In distribution | |
| 5825-300-22 | In distribution | |
| 5955-020-22 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Parafleet SC 018 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 1,460 |
| 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 |
| Castor 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 |
|---|---|
| K241025 | 2024-06-11 |
| K202231 | 2020-12-10 |
| K201794 | 2020-07-28 |
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.