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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K924642
Device Name MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER
Applicant
Medtronic Bio-Medicus, Inc.
9600 W. 76th St.
Eden Prairie,  MN  55344
Applicant Contact THOMAS K JOHNSEN
Correspondent
Medtronic Bio-Medicus, Inc.
9600 W. 76th St.
Eden Prairie,  MN  55344
Correspondent Contact THOMAS K JOHNSEN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/14/1992
Decision Date 03/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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