Fustar
by LifeTech Scientific (Europe) B.V. 19 variants
Ref LE-SVA10F-550, LE-SVA8F-700, LE-SVB9F-800, LE-SVB14F-700, LE-SVA5F-800, LE-SVA5F-900, LE-SVB14F-800, LE-SVB7F-700, LE-SVB9F-550, LE-SVB5F-900, LE-SVB6F-550, LE-SVB12F-800, LE-SVA6F-900, LE-SVA9F-700, LE-SVA9F-900, LE-SVA10F-700, LE-SVA7F-800, LE-SVA6F-700, LE-SVB5F-700, LE-SVB8F-800, LE-SVB6F-700, LE-SVB10F-550, LE-SVA5F-700, LE-SVA6F-800, LE-SVB10F-900, LE-SVB6F-800, LE-SVB10F-800, LE-SVB14F-550, LE-SVA9F-550, LE-SVA7F-550, LE-SVB14F-900, LE-SVB12F-900, LE-SVB6F-900, LE-SVB10F-700, LE-SVB12F-550, LE-SVB7F-900, LE-SVA7F-700, LE-SVB9F-900
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08720214008006 | Date19 Jul 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Fustar™ Steerable introducer
- Model / Reference
- LE-SVA10F-550, LE-SVA8F-700, LE-SVB9F-800, LE-SVB14F-700, LE-SVA5F-800, LE-SVA5F-900, LE-SVB14F-800, LE-SVB7F-700, LE-SVB9F-550, LE-SVB5F-900, LE-SVB6F-550, LE-SVB12F-800, LE-SVA6F-900, LE-SVA9F-700, LE-SVA9F-900, LE-SVA10F-700, LE-SVA7F-800, LE-SVA6F-700, LE-SVB5F-700, LE-SVB8F-800, LE-SVB6F-700, LE-SVB10F-550, LE-SVA5F-700, LE-SVA6F-800, LE-SVB10F-900, LE-SVB6F-800, LE-SVB10F-800, LE-SVB14F-550, LE-SVA9F-550, LE-SVA7F-550, LE-SVB14F-900, LE-SVB12F-900, LE-SVB6F-900, LE-SVB10F-700, LE-SVB12F-550, LE-SVB7F-900, LE-SVA7F-700, LE-SVB9F-900
- Primary DI / UDI-DI
- 08720214008006, 08720214008129, 08720214007917, 08720214008211, 08720214007818, 08720214008228, 08720214007948, 08720214008167, 08720214008051, 08720214008280, 08720214008020, 08720214007931, 08720214008235, 08720214000482, 08720214008266, 08720214008136, 08720214007832, 08720214008105, 08720214008143, 08720214007900, 08720214008150, 08720214008068, 08720214008099, 08720214007825, 08720214008334, 08720214007887, 08720214007924, 08720214008082, 08720214007993, 08720214007979, 08720214008358, 08720214008341, 08720214008297, 08720214008198, 08720214008075, 08720214008303, 08720214008112, 08720214008327
- Basic UDI-DI
- B-08720214008006, B-08720214008129, B-08720214007917, B-08720214008211, B-08720214007818, B-08720214008228, B-08720214007948, B-08720214008167, B-08720214008051, B-08720214008280, B-08720214008020, B-08720214007931, B-08720214008235, B-08720214000482, B-08720214008266, B-08720214008136, B-08720214007832, B-08720214008105, B-08720214008143, B-08720214007900, B-08720214008150, B-08720214008068, B-08720214008099, B-08720214007825, B-08720214008334, B-08720214007887, B-08720214007924, B-08720214008082, B-08720214007993, B-08720214007979, B-08720214008358, B-08720214008341, B-08720214008297, B-08720214008198, B-08720214008075, B-08720214008303, B-08720214008112, B-08720214008327
- EMDN Code
- P0780 Vascular and cardiac prostheses - accessories
- Device Class
- Class IIa
- EU market of registration
- AustriaBelgiumBulgaria
Manufacturer details
- EUDAMED SRN
- NL-MF-000005742
Other devices from LifeTech Scientific (Europe) B.V.
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No