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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K101406
Device Name ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001
Applicant
Medrad Interventional/Possis
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433
Applicant Contact Doug Atkins
Correspondent
Medrad Interventional/Possis
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433
Correspondent Contact Doug Atkins
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received05/19/2010
Decision Date 06/16/2010
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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