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510(k) K222690

SmartGUIDE deflectable hydrophilic guidewire by Artiria Medical SA — Product Code MOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2023
Date Received
September 6, 2022
Clearance Type
Traditional
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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