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510(k) K151825

Viradius Neurowire by Mivi Neuroscience, Inc. — Product Code MOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2015
Date Received
July 6, 2015
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

Other clearances by Mivi Neuroscience, Inc.

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  • K212402 — MIVI Q Distal Access Catheter (December 16, 2021)
  • K163233 — MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, (April 6, 2017)
  • K151396 — MIVI Mi-AXUS Guide Catheter (December 9, 2015)

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  • K243756 — 0.014” Willow Guidewire (July 17, 2025)
  • K243383 — CHIKAI Nexus 014 (April 21, 2025)
  • K243938 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wir (April 1, 2025)
  • K240871 — Synxess Neurovascular Guidewire (November 18, 2024)
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  • K231954 — Aristotle 18 Guidewire; Aristotle 24 Guidewire (August 1, 2023)