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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 K024118
Device Name ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
Applicant
MICRO THERAPEUTICS, INC.
2 GOODYEAR
IRVINE,  CA  92618
Applicant Contact Bill Hyatt
Correspondent
MICRO THERAPEUTICS, INC.
2 GOODYEAR
IRVINE,  CA  92618
Correspondent Contact Bill Hyatt
Regulation Number870.1210
Classification Product Code
KRA  
Date Received12/16/2002
Decision Date 02/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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