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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K100063
Device Name HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
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 Number870.4450
Classification Product Code
MJN  
Date Received01/11/2010
Decision Date 02/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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