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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K090870
Device Name ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY
Applicant
MICRO THERAPEUTICS, INC.
9775 TOLEDO WAY
IRVINE,  CA  92618
Applicant Contact TOM DAUGHTERS
Correspondent
MICRO THERAPEUTICS, INC.
9775 TOLEDO WAY
IRVINE,  CA  92618
Correspondent Contact TOM DAUGHTERS
Regulation Number870.1210
Classification Product Code
KRA  
Date Received03/30/2009
Decision Date 05/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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