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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coronary Vascular Physiologic Simulation Software
510(k) Number K213657
Device Name DEEPVESSEL FFR
Applicant
Keyamed Na, Inc.
107 Spring St.
Seattle,  WA  98104
Applicant Contact Xiaoxiao Liu
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number870.1415
Classification Product Code
PJA  
Date Received11/19/2021
Decision Date 04/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04828590
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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