EpiAccess System
510(k) K170831
EpiAccess System is a medical device (FDA Class II; FDA product code DYB, Introducer, Catheter) made by Epiep, Inc., cleared under FDA 510(k) K170831 on 9 May 2017, 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 | NumberK170831 | Date9 May 2017 | StatusActive |
Official records
- FDA 510(k) database K170831
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- Withdrawn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 K170831
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 A0005 | A0005 | B300A00050 | — | On the market |
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