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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 K223560
Device Name Plato 17 Microcatheter
Applicant
Scientia Vascular Inc
3487 West 2100 South Suite 100
West Valley City,  UT  84119
Applicant Contact Max Alfonso
Correspondent
Scientia Vascular Inc
3487 West 2100 South Suite 100
West Valley City,  UT  84119
Correspondent Contact Max Alfonso
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received11/28/2022
Decision Date 08/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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