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510(k) K200547

Traxcess 14 SELECT Guidewire by MicroVention, Inc. — Product Code MOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2020
Date Received
March 3, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Wire, Catheter, Neurovasculature
Device Class
Class II
Regulation Number
870.1330
Review Panel
NE
Submission Type

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