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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 K232584
Device Name Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
Applicant
Vein 360, LLC
4460 Lake Forest Dr. Suite 230
Blue Ash,  OH  45242
Applicant Contact Suzanne Meyer
Correspondent
Vein 360, LLC
4460 Lake Forest Dr. Suite 230
Blue Ash,  OH  45242
Correspondent Contact Suzanne Meyer
Regulation Number870.1200
Classification Product Code
OWQ  
Date Received08/25/2023
Decision Date 10/24/2023
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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