EUDAMED device
AngioSculpt OTW PTA Scoring Balloon Catheter
EUDAMED device 00813132022914 · Spectranetics Corporation
Key facts
| Primary DI | 00813132022914 |
|---|---|
| Trade name | AngioSculpt OTW PTA Scoring Balloon Catheter |
| Device name | AngioSculpt PTA Scoring Balloon Catheter |
| Reference or catalog number | 2216-30100 |
| Manufacturer | Spectranetics Corporation |
| Manufacturer SRN | US-MF-000023203 |
| Risk class | Class IIa |
| EMDN code | C010402020101 |
| EMDN description | PTA BALLOON DILATATION CATHETERS |
| Legislation | mdd |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | May 16, 2025 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: