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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K897168
Device Name EPICUTANEO-CAVA CATHETER CODE 2184
Applicant
Vygon Corp.
227 Broadway
Suite 100
New York,  NY  10007
Applicant Contact HARRY A SCHLAKMAN
Correspondent
Vygon Corp.
227 Broadway
Suite 100
New York,  NY  10007
Correspondent Contact HARRY A SCHLAKMAN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/27/1989
Decision Date 04/23/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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