Tri-Wedge PTA Scoring Balloon Dilatation Catheter
168 catalogue numbers from rev 01, listed by Brosmed Medical Co., Ltd., China, under Catheter, Percutaneous, Cutting/Scoring. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
168catalogue numbers in this listing
1510(k) clearance
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 | Brosmed Medical Co., Ltd., China |
|---|---|
| FDA product code | PNO |
| Device type | Catheter, Percutaneous, Cutting/Scoring |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2024-11-12 |
| Record revised | 2025-11-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
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Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K241478 | 2024-10-22 |
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.