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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K895030
Device Name LIFE-LINE(TM) VASCULAR ACCESS SYSTEM
Applicant
Medical Engineering and Development Institute
P.O.Box 2402
West Lafayette,  IN  47906
Applicant Contact FEARNOT, PHD
Correspondent
Medical Engineering and Development Institute
P.O.Box 2402
West Lafayette,  IN  47906
Correspondent Contact FEARNOT, PHD
Regulation Number880.5965
Classification Product Code
LJT  
Date Received08/08/1989
Decision Date 04/17/1990
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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