EUDAMED device

AngioSculpt PTCA RX Scoring Balloon Catheter

EUDAMED device 00813132021238 · Spectranetics Corporation

Key facts

Primary DI 00813132021238
Trade name AngioSculpt PTCA RX Scoring Balloon Catheter
Device name AngioSculpt PTCA RX Scoring Balloon Catheter
Reference or catalog number 2200-3510
Manufacturer Spectranetics Corporation
Manufacturer SRN US-MF-000023203
Risk class Class III
EMDN code C010401020101
EMDN description PTCA BALLOON DILATION CATHETERS
Legislation mdd
Implantable No
Sterile Yes
Single use Yes
Status date Apr 30, 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:

Browse all EUDAMED devices