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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reprocessed Intravascular Ultrasound Catheter
510(k) Number K230928
Device Name Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
Applicant
Vein 360, LLC
4460 Lake Forest Dr. Suite 230
Blue Ash,  OH  45242 3741
Applicant Contact Suzanne Meyer
Correspondent
Vein 360, LLC
4460 Lake Forest Dr. Suite 230
Blue Ash,  OH  45242 3741
Correspondent Contact Suzanne Meyer
Regulation Number870.1200
Classification Product Code
OWQ  
Date Received04/03/2023
Decision Date 08/25/2023
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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