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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K260002
Device Name Socrates Aspiration System (Socrates 70 Aspiration 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
NRY  
Date Received01/02/2026
Decision Date 07/16/2026
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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