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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
510(k) Number K210601
Device Name Plato 17 Microcatheter
Applicant
Scientia Vascular LLC
3487 West 2100 South Suite 100
West Valley City,  UT  84119
Applicant Contact Amy McManus
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
QJP  
Date Received03/01/2021
Decision Date 04/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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