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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 K260223
Device Name Aristotle Mini Guidewire
Applicant
Scientia Vascular, Inc.
2460 S. 3270 W.
West Valley City,  UT  84119
Applicant Contact Jamila Abou-Bakr
Correspondent
Scientia Vascular, Inc.
2460 S. 3270 W.
West Valley City,  UT  84119
Correspondent Contact Jamila Abou-Bakr
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received01/26/2026
Decision Date 08/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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