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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 K972610
Device Name POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C
Applicant
Possis Medical, Inc.
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433 -8003
Applicant Contact JAMES D GUSTAFSON
Correspondent
Possis Medical, Inc.
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433 -8003
Correspondent Contact JAMES D GUSTAFSON
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received07/14/1997
Decision Date 04/11/2000
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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