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510(k) K113289

ORION MICRO CATHETER by Micro Therapeutics, Inc. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2012
Date Received
November 7, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

Other clearances by Micro Therapeutics, Inc.

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  • 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)
  • K050543 — NEXUS DETACHABLE COIL SYSTEM (April 27, 2005)

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