MediGuide™ DS2M030
MediGuide™ DS2M030 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K142254 on 13 Nov 2014 and listed in FDA GUDID since 29 Apr 2016 (UDI-DI 05415067003850), 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 | Number05415067003850 | Date29 Apr 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142254 | Date13 Nov 2014 | StatusActive |
Official records
- AccessGUDID record 05415067003850
- FDA 510(k) database K142254
Across registries
- FDA 510(k) K142254 decided 13 Nov 2014 Active
- FDA GUDID UDI-DI 05415067003850 listed 29 Apr 2016 Listed
Timeline
- Cleared FDA 510(k) K142254
- Listed FDA GUDID 05415067003850
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MediGuide™
- Generic name
- Torque manipulation device
- Model / Ref / Catalog
- DS2M030
- Primary DI / UDI-DI
- 05415067003850
- 510(k) Number
- FDA product code
- DQX
- GMDN term
- Torque manipulation device
- Device class
- Class II
- Regulation number
- 870.1330
- GUDID distribution status
- In Commercial Distribution
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