Alatus VBP-40
Alatus VBP-40 is a medical device (FDA Class II) made by Angiodynamics, Inc., cleared under FDA 510(k) K092534 on 7 Dec 2009 and listed in FDA GUDID since 2 Jan 2024 (UDI-DI H787VBP400), 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 | NumberH787VBP400 | Date2 Jan 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092534 | Date7 Dec 2009 | StatusActive |
Official records
- FDA 510(k) database K092534
Across registries
- FDA 510(k) K092534 decided 7 Dec 2009 Active
- FDA GUDID UDI-DI H787VBP400 listed 2 Jan 2024 Listed
Timeline
- Cleared FDA 510(k) K092534
- Listed FDA GUDID H787VBP400
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Alatus
- Generic name
- Radiation therapy lesion localization urethral catheter, planning
- Model / reference
- VBP-40
- Primary DI / UDI-DI
- H787VBP400
- 510(k) Number
- FDA product code
- JAQ, IYE
- GMDN term
- Radiation therapy lesion localization urethral catheter, planning
- Device class
- Class II
- Regulation number
- 892.5700, 892.5050
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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