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FDA 510(k) Application Details - K161879
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K161879
Device Name
Catheter, Thrombus Retriever
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618 US
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Contact
Ryan Kenney
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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
07/08/2016
Decision Date
09/21/2016
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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