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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 K141275
Device Name ENDOPHYS PRESSURE SENSING SHEATH KIT
Applicant
Endophys, Inc.
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Applicant Contact RONALD S WARREN
Correspondent
Endophys, Inc.
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Correspondent Contact RONALD S WARREN
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
DXO  
Date Received05/16/2014
Decision Date 01/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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