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510(k) K033372

SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS by Micro Therapeutics, Inc. — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2004
Date Received
October 22, 2003
Clearance Type
Traditional
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, 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)
  • K081465 — AXIUM DETACHABLE COIL SYSTEM (August 19, 2008)
  • 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)

Other clearances for product code HCG

  • K254221 — Optima Coil System (OptiOne Coil System) (January 27, 2026)
  • K252694 — Target Detachable Coil (December 11, 2025)
  • K251832 — InZone IST Detachment System; IZDS Connecting Cable (October 17, 2025)
  • 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)
  • K233420 — Axium Detachable Coil; Axium Prime Detachable Coil (November 7, 2023)
  • K230284 — Penumbra LP Coil System (October 25, 2023)