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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, peripheral, atherectomy
510(k) Number K960970
Device Name POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P
Applicant
POSSIS MEDICAL, INC.
2905 NORTHWEST BLVD.
minneapolis,  MN  55441 -2644
Applicant Contact james d gustafson
Correspondent
POSSIS MEDICAL, INC.
2905 NORTHWEST BLVD.
minneapolis,  MN  55441 -2644
Correspondent Contact james d gustafson
Regulation Number870.4875
Classification Product Code
MCW  
Date Received03/11/1996
Decision Date 12/03/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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