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FDA 510(k) Application Details - K150616
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K150616
Device Name
Catheter, Thrombus Retriever
Applicant
Concentric Medical, Inc.
301 East Evelyn Avenue
Mountain View, CA 94041 US
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Contact
Rhoda M. Santos
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
03/10/2015
Decision Date
06/12/2015
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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