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FDA 510(k) Application Details - K141516
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K141516
Device Name
Catheter, Thrombus Retriever
Applicant
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 TOLEDO WAY
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
NRY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/09/2014
Decision Date
02/05/2015
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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