Cardiodrive System II
by Stereotaxis, Inc. 3 variants
Cardiodrive System II (001-004115-9) is a Class II device made by Stereotaxis, Inc., cleared under FDA 510(k) K071029 on 24 Aug 2007 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI M58800100411590), 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 | NumberM58800100411590 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071029 | Date24 Aug 2007 | StatusActive |
Official records
- FDA 510(k) database K071029
Across registries
- FDA 510(k) K071029 decided 24 Aug 2007 Active
- FDA GUDID UDI-DI M58800100411590 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K071029
- Listed FDA GUDID M58800100411590
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cardiodrive System
- Generic name
- Cardiac mapping system workstation
- Model / Ref / Catalog
- II, 001-004115-9
- Primary DI / UDI-DI
- M58800100411590
- 510(k) Number
- FDA product code
- DQX
- GMDN term
- Cardiac mapping system workstation
- Device class
- Class II
- Regulation number
- 870.1330
- GUDID distribution status
- In Commercial Distribution
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