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FDA 510(k) Application Details - K162970
Device Classification Name
More FDA Info for this Device
510(K) Number
K162970
Device Name
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator
Applicant
Inari Medical
9272 Jeronimo Rd., Suite 124
Irvine, CA 92618 US
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Contact
Eben Gordon
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/24/2016
Decision Date
11/22/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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