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FDA 510(k) Application Details - K200547
Device Classification Name
Guide, Wire, Catheter, Neurovasculature
More FDA Info for this Device
510(K) Number
K200547
Device Name
Guide, Wire, Catheter, Neurovasculature
Applicant
MicroVention Inc.
35 Enterprise
Aliso Viejo, CA 92656 US
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Contact
Ganesh Balachandar
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
MOF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/03/2020
Decision Date
04/16/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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