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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 N. Rd.
Suite G
Sudbury,  MA  01776
Applicant Contact Padmini Gagnon
Correspondent
Gentuity, LLC
142 N. Rd.
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
Predetermined Change
Control Plan Authorized		 No
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