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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 K180620
Device Name Endophys Pressure Sensing Sheath Kit
Applicant
Endophys Holdings, LLC
1601 Elm St., Suite 3500
Dallas,  TX  75201
Applicant Contact Phillip Purdy
Correspondent
Sachs & Associates, Inc.
5116 Birch Rd.
Minnetonka,  MN  55345
Correspondent Contact Gregory W. Sachs
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
DXO  
Date Received03/09/2018
Decision Date 10/12/2018
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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