Concerto NV-4-8-Helix
Concerto NV-4-8-Helix is a Class II device made by Micro Therapeutics, Inc., cleared under FDA 510(k) K090046 on 27 Feb 2009 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 00836462013032), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00836462013032 | Date16 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090046 | Date27 Feb 2009 | StatusActive |
Official records
- AccessGUDID record 00836462013032
- FDA 510(k) database K090046
Across registries
- FDA 510(k) K090046 decided 27 Feb 2009 Active
- FDA GUDID UDI-DI 00836462013032 listed 16 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K090046
- Listed FDA GUDID 00836462013032
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Concerto
- Generic name
- Neurovascular embolization coil
- Model / Ref / Catalog
- NV-4-8-HELIX
- Primary DI / UDI-DI
- 00836462013032
- 510(k) Number
- FDA product code
- KRD
- GMDN term
- Neurovascular embolization coil
- Device class
- Class II
- Regulation number
- 870.3300
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Length — 8 CentimeterOuter Diameter — 4 Millimeter