CareLink SmartSync™ Common Application M01G02
CareLink SmartSync™ Common Application M01G02 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K163008 on 28 Feb 2017 and listed in FDA GUDID since 25 May 2017 (UDI-DI 00643169833715), active as of 22 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 | Number00643169833715 | Date25 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163008 | Date28 Feb 2017 | StatusActive |
Official records
- AccessGUDID record 00643169833715
- FDA 510(k) database K163008
Across registries
- FDA 510(k) K163008 decided 28 Feb 2017 Active
- FDA GUDID UDI-DI 00643169833715 listed 25 May 2017 Listed
Timeline
- Cleared FDA 510(k) K163008
- Listed FDA GUDID 00643169833715
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CareLink SmartSync™ Common Application
- Generic name
- Implantable cardiac device management application software
- Model / reference
- M01G02
- Primary DI / UDI-DI
- 00643169833715
- 510(k) Number
- FDA product code
- DTC, DTA
- GMDN term
- Implantable cardiac device management application software
- Device class
- Class II
- Regulation number
- 870.3630, 870.3720
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Implantable cardiac device management application software.