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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 K254181
Device Name Aristotle 65 Macrowire
Applicant
Scientia Vascular
2460 S. 3270 W.
West Valley City,  UT  84119
Applicant Contact Bailey Johannsen
Correspondent
Scientia Vascular
2460 S. 3270 W.
West Valley City,  UT  84119
Correspondent Contact Bailey Johannsen
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received12/23/2025
Decision Date 09/16/2026
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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