Globe® Controller 601-00048
by Kardium Inc
Globe® Controller 601-00048 is a Class II device made by Kardium Inc, cleared under FDA 510(k) K250747 on 25 Jun 2025 and listed in FDA GUDID since 15 Sep 2025 (UDI-DI 07540162100291), 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 | Number07540162100291 | Date15 Sep 2025 | StatusListed |
| United States | FDA 510(k) | NumberK250747 | Date25 Jun 2025 | StatusActive |
Official records
- AccessGUDID record 07540162100291
- FDA 510(k) database K250747
Across registries
- FDA 510(k) K250747 decided 25 Jun 2025 Active
- FDA GUDID UDI-DI 07540162100291 listed 15 Sep 2025 Listed
Timeline
- Cleared FDA 510(k) K250747
- Listed FDA GUDID 07540162100291
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Globe® Controller
- Generic name
- Cardiac mapping system
- Model / reference
- 601-00048
- Primary DI / UDI-DI
- 07540162100291
- 510(k) Number
- FDA product code
- DQK
- GMDN term
- Cardiac mapping system
- Device class
- Class II
- Regulation number
- 870.1425
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Cardiac mapping system.