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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Wire, Catheter, Neurovasculature
510(k) Number K222437
Device Name Aristotle Colossus Guidewire
Applicant
Scientia Vascular, Inc.
3487 W. 2100 S., Suite 100
West Valley City,  UT  84119
Applicant Contact Max Alfonso
Correspondent
Scientia Vascular, Inc.
3487 W. 2100 S., Suite 100
West Valley City,  UT  84119
Correspondent Contact Max Alfonso
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received08/12/2022
Decision Date 01/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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