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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 K092495
Device Name HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315
Applicant
Ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Applicant Contact LAURIE E CARTWRIGHT
Correspondent
Ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Correspondent Contact LAURIE E CARTWRIGHT
Regulation Number870.4450
Classification Product Code
MJN  
Date Received08/14/2009
Decision Date 09/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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