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510(k) K151396

MIVI Mi-AXUS Guide Catheter by Mivi Neuroscience, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2015
Date Received
May 26, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • K151825 — Viradius Neurowire (November 16, 2015)

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