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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 K042187
Device Name ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90
Applicant
MICRO THERAPEUTICS, INC.
2 GOODYEAR
IRVINE,  CA  92618
Applicant Contact MARILYN R POURAZAR
Correspondent
MICRO THERAPEUTICS, INC.
2 GOODYEAR
IRVINE,  CA  92618
Correspondent Contact MARILYN R POURAZAR
Regulation Number870.1210
Classification Product Code
KRA  
Date Received08/12/2004
Decision Date 09/02/2004
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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