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EpiAccess Control Unit A0005

by Epiep, Inc.

EpiAccess Control Unit A0005 is a Class II device made by Epiep, Inc., cleared under FDA 510(k) K170831 on 9 May 2017 and listed in FDA GUDID since 18 Sep 2017 (UDI-DI B300A00050), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K170831

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB300A00050 UDI-DI Date18 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK170831 Date9 May 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170831 decided 9 May 2017 Active
  • FDA GUDID UDI-DI B300A00050 listed 18 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170831
  2. Listed FDA GUDID B300A00050

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EpiAccess Control Unit
Generic name
Cardiac catheterization monitoring system
Model / reference
A0005
Primary DI / UDI-DI
B300A00050
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

Related devices

Category: Cardiac catheterization monitoring system

Similar devices

Other devices filed under FDA product code DYB (Introducer, Catheter).

Other devices from Epiep, Inc.

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)