Peripheral Scoring Balloon Dilatation Catheter
Peripheral Scoring Balloon Dilatation Catheter from DK Medical is an over-the-wire catheter for peripheral angioplasty, including obstructive lesions in native or synthetic arteriovenous…
Peripheral Scoring Balloon Dilatation Catheter from DK Medical is an over-the-wire catheter for peripheral angioplasty, including obstructive lesions in native or synthetic arteriovenous dialysis fistulae. It is not intended for coronary use.
A noncompliant balloon carries three longitudinal scoring elements on its outer surface. Two radiopaque marker bands beneath the balloon help position the treatment segment under fluoroscopy, and a tapered tip and lubricious coating assist advancement.
Sizes and Connections
Balloon diameters range from 2.5 to 7.0 mm and lengths from 20 to 150 mm. Catheter lengths are 90, 135 and 150 cm, with 0.014-inch or 0.018-inch guidewire compatibility as applicable. Separate hub ports accept the guidewire and control balloon inflation. The device has no in-stent restenosis indication.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | DK Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | PNO |
| Device type | Catheter, Percutaneous, Cutting/Scoring |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Manufacturer |
| 510(k) | K242254 |
| Record published | 2026-06-24 |
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 |
|---|---|---|
| DKL14-2560C | In distribution | |
| DKL14-2580C | In distribution | |
| DKL14-25150B | In distribution | |
| DKL14-2580B | In distribution | |
| DKL14-2540C | In distribution | |
| DKL14-25100B | In distribution | |
| DKL14-25120B | In distribution | |
| DKL14-2540B | In distribution | |
| DKL14-2560B | In distribution | |
| DKL14-2520C | In distribution | |
| DKL14-2520B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 168 |
| PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | 120 |
| VascuTrak® | Bard Peripheral Vascular, Inc. | 109 |
| Ultrascore | Bard Peripheral Vascular, Inc. | 103 |
| Scoreflex PTA Scoring Balloon Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 58 |
| AngioSculpt® | Spectranetics Corp. | 51 |
| Aperta NSE™ PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | 38 |
| AngioSculpt OTW PTA Scoring Balloon Catheter | The Spectranetics Corp. | 25 |
| Serranator | Cagent Vascular | 18 |
| AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating | The Spectranetics Corp. | 13 |
| Advance Enforcer | Cook Incorporated | 12 |
| 2cm Peripheral Cutting Balloon® | Boston Scientific Corporation | 12 |
Showing 12 of 16. All products under Catheter, Percutaneous, Cutting/Scoring
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242254 | 2025-04-21 |
| K232207 | 2024-03-07 |
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.