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FDA 510(k) Application Details - K201690
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K201690
Device Name
Wire, Guide, Catheter
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618 US
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Contact
Prerana Gurubasavaraj
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
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More FDA Info for this Product Code
Date Received
06/22/2020
Decision Date
07/21/2020
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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