PTA Scoring Balloon Dilatation Catheter
D·Kutting is an over-the-wire scoring-balloon catheter for angioplasty of obstructive lesions in dialysis fistulae. Three wires mounted on the balloon surface form the scoring element and…
D·Kutting is an over-the-wire scoring-balloon catheter for angioplasty of obstructive lesions in dialysis fistulae. Three wires mounted on the balloon surface form the scoring element and are spaced 120 degrees apart.
One shaft lumen follows a guidewire and the other inflates the balloon. A proximal Y-manifold provides Luer-lock connections, while marker bands bracket the scoring-wire segment.
Guidewire and Balloon Options
Configurations accept 0.018-inch or 0.035-inch guidewires. Balloon diameters range from 4 to 8 mm and lengths from 20 to 80 mm, with catheter lengths of 50, 90 or 130 cm. The PVP-coated tip supports insertion and withdrawal, and the hub identifies balloon size and guidewire compatibility.
3manufacturers in China registered for this device type
120catalogue numbers in this listing
2510(k) clearances naming this product code
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) | K232207 |
| Record published | 2025-07-24 |
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 |
|---|---|---|
| DKT18-6060C | In distribution | |
| DKT35-5040C | In distribution | |
| DKT18-6080C | In distribution | |
| DKT35-8040C | In distribution | |
| DKT35-7040B | In distribution | |
| DKT35-5040A | In distribution | |
| DKT18-6020C | In distribution | |
| DKT35-8060C | In distribution | |
| DKT18-4060B | In distribution | |
| DKT35-7060A | In distribution | |
| DKT35-8040A | In distribution | |
| DKT18-5040B | In distribution | |
| DKT35-7060C | In distribution | |
| DKT18-8020C | In distribution | |
| DKT18-8060A | In distribution | |
| DKT18-4040B | In distribution | |
| DKT35-6060C | In distribution | |
| DKT18-4080A | In distribution | |
| DKT35-4080A | In distribution | |
| DKT35-4080C | In distribution | |
| DKT18-6060A | In distribution | |
| DKT35-7080A | In distribution | |
| DKT35-8040B | In distribution | |
| DKT35-6080B | In distribution | |
| DKT35-4020B | In distribution | |
| DKT18-7040C | In distribution | |
| DKT18-7060A | In distribution | |
| DKT18-5060A | In distribution | |
| DKT35-4040A | In distribution | |
| DKT35-7020C | In distribution | |
| DKT18-8020A | In distribution | |
| DKT35-7040C | In distribution | |
| DKT35-6040B | In distribution | |
| DKT18-5020B | In distribution | |
| DKT35-5080B | In distribution | |
| DKT18-5020A | In distribution | |
| DKT18-6040C | In distribution | |
| DKT35-8080A | In distribution | |
| DKT18-8080A | In distribution | |
| DKT18-5060B | In distribution | |
| DKT18-6080A | In distribution | |
| DKT18-8080B | In distribution | |
| DKT35-4080B | In distribution | |
| DKT18-8060B | In distribution | |
| DKT35-5060A | In distribution | |
| DKT18-4020C | In distribution | |
| DKT18-7040A | In distribution | |
| DKT35-4040B | In distribution | |
| DKT35-8060A | In distribution | |
| DKT35-6040C | In distribution | |
| DKT35-5020C | In distribution | |
| DKT18-7040B | In distribution | |
| DKT18-7080B | In distribution | |
| DKT18-8040A | In distribution | |
| DKT18-5020C | In distribution | |
| DKT18-4020A | In distribution | |
| DKT18-7020A | In distribution | |
| DKT18-8020B | In distribution | |
| DKT18-5060C | In distribution | |
| DKT35-4060C | In distribution | |
| DKT35-8020C | In distribution | |
| DKT18-6040A | In distribution | |
| DKT35-5060B | In distribution | |
| DKT18-5080C | In distribution | |
| DKT18-4020B | In distribution | |
| DKT18-4060C | In distribution | |
| DKT35-4060A | In distribution | |
| DKT35-7060B | In distribution | |
| DKT35-4040C | In distribution | |
| DKT18-7080C | In distribution | |
| DKT35-5060C | In distribution | |
| DKT35-5020B | In distribution | |
| DKT18-4060A | In distribution | |
| DKT35-8060B | In distribution | |
| DKT35-7080C | In distribution | |
| DKT18-6020B | In distribution | |
| DKT35-6060B | In distribution | |
| DKT18-6020A | In distribution | |
| DKT18-4040A | In distribution | |
| DKT35-8080B | In distribution | |
| DKT35-6060A | In distribution | |
| DKT18-8040C | In distribution | |
| DKT35-4020C | In distribution | |
| DKT18-4040C | In distribution | |
| DKT35-7020B | In distribution | |
| DKT18-5040A | In distribution | |
| DKT18-6080B | In distribution | |
| DKT35-6080C | In distribution | |
| DKT35-5080A | In distribution | |
| DKT35-6020A | In distribution | |
| DKT18-5040C | In distribution | |
| DKT35-5020A | In distribution | |
| DKT18-5080B | In distribution | |
| DKT35-6080A | In distribution | |
| DKT18-8040B | In distribution | |
| DKT35-7040A | In distribution | |
| DKT35-8080C | In distribution | |
| DKT35-7080B | In distribution | |
| DKT35-5080C | In distribution | |
| DKT18-7080A | In distribution | |
| DKT35-6020B | In distribution | |
| DKT35-5040B | In distribution | |
| DKT18-7060B | In distribution | |
| DKT18-7020C | In distribution | |
| DKT35-8020B | In distribution | |
| DKT35-8020A | In distribution | |
| DKT35-7020A | In distribution | |
| DKT35-4060B | In distribution | |
| DKT18-8080C | In distribution | |
| DKT18-6060B | In distribution | |
| DKT18-4080C | In distribution | |
| DKT18-7060C | In distribution | |
| DKT18-7020B | In distribution | |
| DKT18-4080B | In distribution | |
| DKT35-6020C | In distribution | |
| DKT18-8060C | In distribution | |
| DKT35-6040A | In distribution | |
| DKT35-4020A | In distribution | |
| DKT18-6040B | In distribution | |
| DKT18-5080A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 168 |
| 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 |
| Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | 11 |
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.