Jade PTA Balloon Dilatation Catheter
The FDA filing names the JADE PTA Balloon Dilatation Catheter for peripheral indications, matching the listed product. The filing states its indications include angioplasty in peripheral…
The FDA filing names the JADE PTA Balloon Dilatation Catheter for peripheral indications, matching the listed product.
The filing states its indications include angioplasty in peripheral arteries and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.
Listed Item
Percutaneous Transluminal Angioplasty (PTA) Catheter
Catheter Construction
The source gives balloon diameter and length ranges, catheter lengths, and describes a minimally compliant balloon with distal hydrophilic coating. Rated burst pressure is 18 atmospheres for 5.0 to 6.0 mm balloons and 20 atmospheres for 1.5 to 4.0 mm balloons.
5manufacturers in China registered for this device type
667catalogue 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) | K201794 |
| Record published | 2020-11-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 586024022 | In distribution | |
| 607010022 | In distribution | |
| 596012012 | In distribution | |
| 584018022 | In distribution | |
| 593512022 | In distribution | |
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| 603015032 | In distribution | |
| 597001522 | In distribution | |
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| 606015022 | In distribution | |
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| 586006032 | In distribution | |
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| 582008022 | In distribution | |
| 593006032 | In distribution | |
| 595010012 | In distribution | |
| 596018022 | In distribution | |
| 604008032 | In distribution | |
| 585012012 | In distribution | |
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| 583004032 | In distribution | |
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| 606004022 | In distribution | |
| 556006012 | In distribution | |
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| 557010012 | In distribution | |
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| 592512032 | In distribution | |
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| 585004022 | In distribution | |
| 597002012 | In distribution | |
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| 583512032 | In distribution | |
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| 582002012 | In distribution | |
| 594502032 | In distribution | |
| 583024032 | In distribution | |
| 595001512 | In distribution | |
| 593518032 | In distribution | |
| 593015022 | In distribution | |
| 593018032 | In distribution | |
| 594504012 | In distribution | |
| 551504012 | In distribution | |
| 582515022 | In distribution | |
| 603008032 | In distribution | |
| 555008012 | In distribution | |
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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 Plus PTA Balloon Dilatation Catheter / Jade Plus 18 OTW | OrbusNeich Medical (Shenzhen) Co., Ltd. | 832 |
| 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.