Supportrak®
by Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation United States EUDAMED
Ref 6668
EMDN C04010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number01915060000000000000389NR | Date6 Nov 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 790669 Issued
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 14 Feb 2024
- Expires
- 13 Feb 2029
Specification
- Device Name
- SUPPORTRAK™ Finishing Wire
- Model / Reference
- 6668
- Primary DI / UDI-DI
- 00802526524851
- Basic UDI-DI
- 01915060000000000000389NR
- EMDN Code
- C04010201 Coronary artery therapeutic guidewires, hydrophilic
- Device Class
- Class III
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000010993
- Authorised representative
- Guidant Europe NV/SA; Boston Scientific BE-AR-000008410
Other devices from Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation
See all devices from Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation →
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 00802526524851|01915060000000000000389NR