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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 K231588
Device Name ViewFlex™ Eco Reprocessed ICE Catheter
Applicant
Abbott Medical
14901 De Veau Place
Minnetonka,  MN  55345
Applicant Contact Quynh Phuong Le
Correspondent
Abbott Medical
14901 De Veau Place
Minnetonka,  MN  55345
Correspondent Contact Quynh Phuong Le
Regulation Number870.1200
Classification Product Code
OWQ  
Date Received06/01/2023
Decision Date 06/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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