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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 K030688
FOIA Releasable 510(k) K030688
Device Name ECHELON MICRO CATHETER, MODEL 105-5092-150
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 Received03/05/2003
Decision Date 03/28/2003
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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