HeartCentrix 11098-002-50
HeartCentrix 11098-002-50 is a Class II device made by Mortara Instrument, Inc., cleared under FDA 510(k) K032038 on 5 Sep 2003 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345029994), 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 | Number00812345029994 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK032038 | Date5 Sep 2003 | StatusActive |
Official records
- AccessGUDID record 00812345029994
- FDA 510(k) database K032038
Across registries
- FDA 510(k) K032038 decided 5 Sep 2003 Active
- FDA GUDID UDI-DI 00812345029994 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K032038
- Listed FDA GUDID 00812345029994
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HeartCentrix
- Generic name
- Patient health record information system application software
- Model / reference
- 11098-002-50
- Primary DI / UDI-DI
- 00812345029994
- 510(k) Number
- FDA product code
- DQK
- GMDN term
- Patient health record information system application software
- Device class
- Class II
- Regulation number
- 870.1425
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Patient health record information system application software.