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510(k) K202850

Concerto Versa, Detachable Coil by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2021
Date Received
September 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
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)
  • K211990 — Rist 071 Radial Access Guide Catheter (July 27, 2021)
  • K203432 — Axium Detachable Coil; Axium Prime Detachable Coil (July 7, 2021)
  • K203358 — Solitaire X Revascularization Device (March 1, 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)
  • K201690 — Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire (July 21, 2020)

Other clearances for product code KRD

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  • K253677 — Tembo Embolic System (December 15, 2025)
  • K253376 — OBSIDIO™ Conformable Embolic (M0013972101010) (October 30, 2025)
  • K250209 — Polyvinyl Alcohol Embolic Microspheres (September 23, 2025)
  • K250133 — HARBOR Occlusion Device (July 9, 2025)
  • K251383 — Prestige Coil System (Prestige Packing Line Extension) (May 30, 2025)
  • K250971 — Embosphere Microspheres (May 16, 2025)
  • K250276 — Nitinol Enhanced Device (NED) (May 15, 2025)
  • K250079 — Ruby XL System (March 14, 2025)
  • K242608 — Embozene Color-Advanced Microspheres (January 17, 2025)