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510(k) K210358

Neurescue device by Neurescue Aps — Product Code MJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2021
Date Received
February 8, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular Occluding, Temporary
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

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