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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Carotid Catheter For Embolic Capture
510(k) Number K222694
Device Name EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
Applicant
MicroVention, Inc.
35 Enterprise
Aliso Viejo,  CA  92656
Applicant Contact Ganesh Balachandar
Correspondent
MicroVention, Inc.
35 Enterprise
Aliso Viejo,  CA  92656
Correspondent Contact Sapna Singh
Regulation Number870.1250
Classification Product Code
NTE  
Date Received09/06/2022
Decision Date 04/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT02657707
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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