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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 K093750
Device Name ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA
Applicant
EV3 INC
9775 TOLEDO WAY
IRVINE,  CA  92618
Applicant Contact Laura Heaton
Correspondent
EV3 INC
9775 TOLEDO WAY
IRVINE,  CA  92618
Correspondent Contact Laura Heaton
Regulation Number870.1210
Classification Product Code
KRA  
Date Received12/07/2009
Decision Date 12/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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