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FDA 510(k) Application Details - K203358
Device Classification Name
More FDA Info for this Device
510(K) Number
K203358
Device Name
Solitaire X Revascularization Device
Applicant
Micro Therapeutics, Inc d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618 US
Other 510(k) Applications for this Company
Contact
Kevin Kong
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
POL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/16/2020
Decision Date
03/01/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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