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FDA 510(k) Application Details - K181807
Device Classification Name
More FDA Info for this Device
510(K) Number
K181807
Device Name
Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire 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
Jennifer Correa
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
07/06/2018
Decision Date
03/06/2019
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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