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510(k) K081465

AXIUM DETACHABLE COIL SYSTEM by Micro Therapeutics, Inc. — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2008
Date Received
May 27, 2008
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.

  • K113289 — ORION MICRO CATHETER (August 1, 2012)
  • K113454 — 14 WIRE STANDARD, 14 WIRE LS (February 24, 2012)
  • K090870 — ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA (May 1, 2009)
  • K090046 — CONCERTO DETACHABLE COIL SYSTEM (February 27, 2009)
  • K060747 — FX DETACHABLE COIL SYSTEM (April 24, 2007)
  • K060625 — NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR (April 20, 2006)
  • K051990 — ECHELON MICRO CATHETER (January 4, 2006)
  • K051560 — NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR (June 28, 2005)
  • K051425 — NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR (June 22, 2005)
  • K050543 — NEXUS DETACHABLE COIL SYSTEM (April 27, 2005)

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  • 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)