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FDA 510(k) Application Details - K211120
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K211120
Device Name
Catheter, Thrombus Retriever
Applicant
MicroVention Inc.
35 Enterprise
Aliso Viejo, CA 92656 US
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Contact
Stephanie Onstot
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
NRY
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More FDA Info for this Product Code
Date Received
04/15/2021
Decision Date
03/31/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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