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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K142245
Device Name EpiAccess System
Applicant
Epiep, Inc.
142 Temple St., Suite 206
New Haven,  CT  06510
Applicant Contact Pamela Bunes
Correspondent
Cygnus Regulatory
8 Grandin Ln.
Cincinnati,  OH  45208
Correspondent Contact Elsa Abruzzo
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/13/2014
Decision Date 10/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT02209064
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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