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FDA 510(k) Application Details - K210114
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
510(K) Number
K210114
Device Name
Catheter, Continuous Flush
Applicant
Micro Therapeuatics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618 US
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Contact
Catherine Chiou
Other 510(k) Applications for this Contact
Regulation Number
870.1210
More FDA Info for this Regulation Number
Classification Product Code
KRA
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More FDA Info for this Product Code
Date Received
01/19/2021
Decision Date
02/16/2021
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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