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510(k) K201690

Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2020
Date Received
June 22, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K203432 — Axium Detachable Coil; Axium Prime Detachable Coil (July 7, 2021)
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  • K202850 — Concerto Versa, Detachable Coil (February 9, 2021)
  • K193576 — Solitaire Platinum Revascularization Device, Solitaire X Revascularization Devic (November 20, 2020)
  • K202318 — Marathon Flow Directed Micro Catheter (September 14, 2020)
  • K201689 — Riptide Aspiration System (July 21, 2020)

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  • K252674 — Solo Pace Fusion System (SOLOFUSE1) (January 9, 2026)
  • K251596 — Lunderquist Extra Stiff Wire Guide (November 9, 2025)
  • K250203 — SureAx-Guide™ (October 17, 2025)
  • K250031 — Amplatzer Guidewire (October 3, 2025)
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  • K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (July 25, 2025)
  • K250075 — Medtronic Stedi Extra Support Guidewire (June 13, 2025)