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510(k) K211990

Rist 071 Radial Access Guide Catheter by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2021
Date Received
June 28, 2021
Clearance Type
Special
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

Other clearances by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

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  • K243080 — Riptide Aspiration System (October 29, 2024)
  • K203432 — Axium Detachable Coil; Axium Prime Detachable Coil (July 7, 2021)
  • K203358 — Solitaire X Revascularization Device (March 1, 2021)
  • 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)
  • K201690 — Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire (July 21, 2020)
  • K201689 — Riptide Aspiration System (July 21, 2020)

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