EpiAccess System
510(k) K142245
EpiAccess System is a medical device (FDA Class II; FDA product code DYB, Introducer, Catheter) made by Epiep, Inc., cleared under FDA 510(k) K142245 on 29 Oct 2014, 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 | FDA 510(k)SESE | NumberK142245 | Date29 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K142245
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DYB
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K142245
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| EpiAccess Control Unit A0002 | A0002 | B300A00020 | On the market | |
| EpiAccess Needle 0399-13950 | 0399-13950 | B3000399139500 | On the market |
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