EpiAccess Control Unit A0002
by Epiep, Inc.
EpiAccess Control Unit A0002 is a Class II device made by Epiep, Inc., cleared under FDA 510(k) K142245 on 29 Oct 2014 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI B300A00020), 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 | NumberB300A00020 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142245 | Date29 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K142245
Across registries
- FDA 510(k) K142245 decided 29 Oct 2014 Active
- FDA GUDID UDI-DI B300A00020 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K142245
- Listed FDA GUDID B300A00020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EpiAccess Control Unit
- Generic name
- Cardiac catheterization monitoring system
- Model / reference
- A0002
- Primary DI / UDI-DI
- B300A00020
- 510(k) Number
- FDA product code
- DYB
- GMDN term
- Cardiac catheterization monitoring system
- Device class
- Class II
- Regulation number
- 870.1340
- GUDID distribution status
- In Commercial Distribution
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