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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Neurovasculature
510(k) Number K242301
Device Name Socrates 38 Catheter
Applicant
Scientia Vascular, Inc.
2460 S. 3270 W.
West Valley City,  UT  84119
Applicant Contact Thomas Lippert
Correspondent
Scientia Vascular, Inc.
2460 S. 3270 W.
West Valley City,  UT  84119
Correspondent Contact Thomas Lippert
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received08/02/2024
Decision Date 12/04/2024
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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