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510(k) K233420

Axium Detachable Coil; Axium Prime Detachable Coil by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2023
Date Received
October 10, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Neurovascular Embolization
Device Class
Class II
Regulation Number
882.5950
Review Panel
NE
Submission Type

Other clearances by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

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  • K210230 — Phenom Catheters (February 25, 2021)

Other clearances for product code HCG

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  • K252700 — Optima Coil System (Optima Packing Coil System) (September 26, 2025)
  • K242154 — Numen™ Coil Embolization System; NumenFR™ Detachment System (September 30, 2024)
  • K242582 — Optima Coil System (OptiBlock Line Extension) (September 27, 2024)
  • K242243 — Target Detachable Coils (August 29, 2024)
  • K232955 — Numen Coil Embolization System; NumenFR Detachment System (January 10, 2024)
  • K230284 — Penumbra LP Coil System (October 25, 2023)
  • K222533 — Target Tetra Detachable Coils (December 14, 2022)