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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 K160272
Device Name Endophys Pressure Sensing Sheath Kit
Applicant
Endophys, Inc.
Thanksgiving Tower, Suite 1930
1601 Elm St.
Dallas,  TX  75201
Applicant Contact Rebecca K Pine
Correspondent
Endophys, Inc.
Thanksgiving Tower, Suite 1930
1601 Elm St.
Dallas,  TX  75201
Correspondent Contact Rebecca K Pine
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
DXO  
Date Received02/02/2016
Decision Date 03/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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