PTA High Pressure Balloon Dilatation Catheter
D·Kaptain PTA High Pressure is an over-the-wire balloon catheter for dilation in peripheral vessels and obstructive dialysis-fistula lesions. One shaft lumen follows a 0.035-inch guidewire,…
D·Kaptain PTA High Pressure is an over-the-wire balloon catheter for dilation in peripheral vessels and obstructive dialysis-fistula lesions. One shaft lumen follows a 0.035-inch guidewire, while another inflates and deflates the balloon.
The lumens connect proximally through a Y-shaped manifold with Luer-lock fittings. Radiopaque bands beneath the balloon support positioning, and a PVP coating covers the tip.
Balloon and Shaft Configurations
Balloon diameters range from 3 to 12 mm and lengths from 20 to 150 mm. Shaft options are 50, 75 or 130 cm. These configurations belong to the peripheral angioplasty family; the catheter is not intended for coronary use.
5manufacturers in China registered for this device type
186catalogue numbers in this listing
1510(k) clearance
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 | DK Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Manufacturer |
| 510(k) | K214009 |
| Record published | 2025-07-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HPA75-5040B5 | In distribution | |
| HPA50-3060A5 | In distribution | |
| HPA75-5030B5 | In distribution | |
| HPA50-60100A5 | In distribution | |
| HPA130-10040C6 | In distribution | |
| HPA50-8080A6 | In distribution | |
| HPA75-80100B6 | In distribution | |
| HPA50-10030A6 | In distribution | |
| HPA75-3030B5 | In distribution | |
| HPA75-7060B5 | In distribution | |
| HPA130-12080C7 | In distribution | |
| HPA75-4060B5 | In distribution | |
| HPA130-3040C5 | In distribution | |
| HPA130-60100C5 | In distribution | |
| HPA130-10020C6 | In distribution | |
| HPA50-40150A5 | In distribution | |
| HPA50-4040A5 | In distribution | |
| HPA130-80150C6 | In distribution | |
| HPA75-30150B5 | In distribution | |
| HPA50-6060A5 | In distribution | |
| HPA130-6030C5 | In distribution | |
| HPA130-7080C5 | In distribution | |
| HPA130-9080C6 | In distribution | |
| HPA75-8080B6 | In distribution | |
| HPA75-3020B5 | In distribution | |
| HPA130-7030C5 | In distribution | |
| HPA130-3080C5 | In distribution | |
| HPA130-12030C7 | In distribution | |
| HPA75-30120B5 | In distribution | |
| HPA50-6040A5 | In distribution | |
| HPA50-4020A5 | In distribution | |
| HPA130-8040C6 | In distribution | |
| HPA130-8060C6 | In distribution | |
| HPA75-5080B5 | In distribution | |
| HPA75-3060B5 | In distribution | |
| HPA75-9060B6 | In distribution | |
| HPA130-6060C5 | In distribution | |
| HPA130-70150C5 | In distribution | |
| HPA50-5040A5 | In distribution | |
| HPA130-9030C6 | In distribution | |
| HPA75-10060B6 | In distribution | |
| HPA50-10060A6 | In distribution | |
| HPA130-80120C6 | In distribution | |
| HPA50-4030A5 | In distribution | |
| HPA130-70120C5 | In distribution | |
| HPA130-6080C5 | In distribution | |
| HPA50-7080A5 | In distribution | |
| HPA130-4020C5 | In distribution | |
| HPA75-70120B5 | In distribution | |
| HPA50-80150A6 | In distribution | |
| HPA50-5020A5 | In distribution | |
| HPA130-40100C5 | In distribution | |
| HPA75-8060B6 | In distribution | |
| HPA75-12030B7 | In distribution | |
| HPA50-3030A5 | In distribution | |
| HPA75-12060B7 | In distribution | |
| HPA50-30150A5 | In distribution | |
| HPA130-4080C5 | In distribution | |
| HPA75-5020B5 | In distribution | |
| HPA75-9080B6 | In distribution | |
| HPA50-8020A6 | In distribution | |
| HPA130-4040C5 | In distribution | |
| HPA130-30150C5 | In distribution | |
| HPA75-6080B5 | In distribution | |
| HPA75-50150B5 | In distribution | |
| HPA50-40120A5 | In distribution | |
| HPA130-7040C5 | In distribution | |
| HPA75-40100B5 | In distribution | |
| HPA75-10030B6 | In distribution | |
| HPA75-3080B5 | In distribution | |
| HPA50-50120A5 | In distribution | |
| HPA75-12080B7 | In distribution | |
| HPA50-9060A6 | In distribution | |
| HPA130-7060C5 | In distribution | |
| HPA130-3030C5 | In distribution | |
| HPA130-4030C5 | In distribution | |
| HPA75-70150B5 | In distribution | |
| HPA130-5060C5 | In distribution | |
| HPA130-50120C5 | In distribution | |
| HPA50-3080A5 | In distribution | |
| HPA75-9040B6 | In distribution | |
| HPA50-12060A7 | In distribution | |
| HPA50-6080A5 | In distribution | |
| HPA75-30100B5 | In distribution | |
| HPA130-8080C6 | In distribution | |
| HPA130-12020C7 | In distribution | |
| HPA75-7020B5 | In distribution | |
| HPA75-80150B6 | In distribution | |
| HPA130-12060C7 | In distribution | |
| HPA130-5020C5 | In distribution | |
| HPA50-12030A7 | In distribution | |
| HPA50-70100A5 | In distribution | |
| HPA75-60120B5 | In distribution | |
| HPA50-4080A5 | In distribution | |
| HPA130-8030C6 | In distribution | |
| HPA75-4030B5 | In distribution | |
| HPA50-70150A5 | In distribution | |
| HPA50-4060A5 | In distribution | |
| HPA50-8030A6 | In distribution | |
| HPA130-10030C6 | In distribution | |
| HPA50-3040A5 | In distribution | |
| HPA130-60150C5 | In distribution | |
| HPA75-60150B5 | In distribution | |
| HPA50-10020A6 | In distribution | |
| HPA130-9040C6 | In distribution | |
| HPA130-50150C5 | In distribution | |
| HPA75-10020B6 | In distribution | |
| HPA75-80120B6 | In distribution | |
| HPA50-5080A5 | In distribution | |
| HPA130-30100C5 | In distribution | |
| HPA75-40120B5 | In distribution | |
| HPA50-30100A5 | In distribution | |
| HPA75-7030B5 | In distribution | |
| HPA50-7040A5 | In distribution | |
| HPA50-12040A7 | In distribution | |
| HPA50-40100A5 | In distribution | |
| HPA75-6030B5 | In distribution | |
| HPA50-10040A6 | In distribution | |
| HPA130-5080C5 | In distribution | |
| HPA50-8060A6 | In distribution | |
| HPA130-50100C5 | In distribution | |
| HPA130-60120C5 | In distribution | |
| HPA130-6040C5 | In distribution | |
| HPA75-70100B5 | In distribution | |
| HPA130-4060C5 | In distribution | |
| HPA130-5030C5 | In distribution | |
| HPA50-80120A6 | In distribution | |
| HPA75-9020B6 | In distribution | |
| HPA50-50100A5 | In distribution | |
| HPA130-70100C5 | In distribution | |
| HPA130-80100C6 | In distribution | |
| HPA50-60120A5 | In distribution | |
| HPA130-40150C5 | In distribution | |
| HPA75-10080B6 | In distribution | |
| HPA50-30120A5 | In distribution | |
| HPA130-10080C6 | In distribution | |
| HPA75-4080B5 | In distribution | |
| HPA50-3020A5 | In distribution | |
| HPA50-60150A5 | In distribution | |
| HPA75-12040B7 | In distribution | |
| HPA50-10080A6 | In distribution | |
| HPA50-7020A5 | In distribution | |
| HPA75-40150B5 | In distribution | |
| HPA130-6020C5 | In distribution | |
| HPA50-12020A7 | In distribution | |
| HPA50-5030A5 | In distribution | |
| HPA75-4040B5 | In distribution | |
| HPA50-9040A6 | In distribution | |
| HPA50-50150A5 | In distribution | |
| HPA75-50120B5 | In distribution | |
| HPA50-9080A6 | In distribution | |
| HPA75-6020B5 | In distribution | |
| HPA75-8030B6 | In distribution | |
| HPA75-10040B6 | In distribution | |
| HPA50-70120A5 | In distribution | |
| HPA50-8040A6 | In distribution | |
| HPA75-6060B5 | In distribution | |
| HPA75-3040B5 | In distribution | |
| HPA130-12040C7 | In distribution | |
| HPA50-9020A6 | In distribution | |
| HPA75-50100B5 | In distribution | |
| HPA75-8040B6 | In distribution | |
| HPA75-9030B6 | In distribution | |
| HPA75-4020B5 | In distribution | |
| HPA75-6040B5 | In distribution | |
| HPA50-5060A5 | In distribution | |
| HPA130-30120C5 | In distribution | |
| HPA130-8020C6 | In distribution | |
| HPA75-8020B6 | In distribution | |
| HPA130-5040C5 | In distribution | |
| HPA50-6030A5 | In distribution | |
| HPA75-12020B7 | In distribution | |
| HPA130-9060C6 | In distribution | |
| HPA50-7030A5 | In distribution | |
| HPA50-12080A7 | In distribution | |
| HPA130-40120C5 | In distribution | |
| HPA130-3060C5 | In distribution | |
| HPA75-7040B5 | In distribution | |
| HPA130-3020C5 | In distribution | |
| HPA50-7060A5 | In distribution | |
| HPA50-80100A6 | In distribution | |
| HPA50-6020A5 | In distribution | |
| HPA130-9020C6 | In distribution | |
| HPA130-10060C6 | In distribution | |
| HPA75-5060B5 | In distribution | |
| HPA50-9030A6 | 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 |
|---|---|
| K214009 | 2023-04-05 |
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.