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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 K101570
Device Name HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS
Applicant
Micro Therapeutics Dba Ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Applicant Contact LAURIE CARTWRIGHT
Correspondent
Micro Therapeutics Dba Ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Correspondent Contact LAURIE CARTWRIGHT
Regulation Number870.4450
Classification Product Code
MJN  
Date Received06/04/2010
Decision Date 07/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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