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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 K931586
Device Name VITAL-PORT MINI VASCULAR ACCESS SYSTEM
Applicant
Med Institute, Inc.
P.O.Box 2402
West Lafayette,  IN  47906
Applicant Contact FEARNOT, PHD
Correspondent
Med Institute, Inc.
P.O.Box 2402
West Lafayette,  IN  47906
Correspondent Contact FEARNOT, PHD
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/31/1993
Decision Date 09/27/1993
Decision Substantially Equivalent - Kit (SESK)
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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