StrataVarius 45809
by Medtronic PS Medical 2 variants
StrataVarius 45809 is a Class II device made by Medtronic PS Medical, cleared under FDA 510(k) K041992 on 28 Jan 2005 and listed in FDA GUDID since 6 Apr 2020 (UDI-DI 00763000266981), 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 | Number00763000266981 | Date6 Apr 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041992 | Date28 Jan 2005 | StatusActive |
Official records
- AccessGUDID record 00763000266981
- FDA 510(k) database K041992
Across registries
- FDA 510(k) K041992 decided 28 Jan 2005 Active
- FDA GUDID UDI-DI 00763000266981 listed 6 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K041992
- Listed FDA GUDID 00763000266981
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- StrataVarius
- Generic name
- Cerebrospinal fluid shunt valve programmer
- Model / reference
- 45809
- Primary DI / UDI-DI
- 00763000266981
- 510(k) Number
- FDA product code
- JXG
- GMDN term
- Cerebrospinal fluid shunt valve programmer
- Device class
- Class II
- Regulation number
- 882.5550
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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