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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K230620
Device Name Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
Applicant
Gentuity, LLC
142 North Road, Suite G
Sudbury,  MA  01776
Applicant Contact Padmini Gagnon
Correspondent
Gentuity, LLC
142 North Road, Suite G
Sudbury,  MA  01776
Correspondent Contact Padmini Gagnon
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
NQQ  
Date Received03/06/2023
Decision Date 08/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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