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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 K071336
Device Name ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
Applicant
Possis Medical, Inc.
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433 -8003
Applicant Contact FRANK B FREEDMAN
Correspondent
Possis Medical, Inc.
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433 -8003
Correspondent Contact FRANK B FREEDMAN
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received05/11/2007
Decision Date 08/24/2007
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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