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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 K861096
Device Name CARDIOPULMONARY CANNULA TUBING
Applicant
Bio Medicus, Inc.
9600 W. 76 St.
Eden Prairie,  MN  55344
Applicant Contact DEBRA P SEE
Correspondent
Bio Medicus, Inc.
9600 W. 76 St.
Eden Prairie,  MN  55344
Correspondent Contact DEBRA P SEE
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/24/1986
Decision Date 05/21/1986
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
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