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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, Short-Term Less Than 30 Days
510(k) Number K910566
Device Name VERSACATH(TM) MULTILUMEN SYSTEM
Applicant
Menlo Care, Inc.
1350 Willow Rd.
Menlo Park,  CA  94025
Applicant Contact JOCK M WALKER
Correspondent
Menlo Care, Inc.
1350 Willow Rd.
Menlo Park,  CA  94025
Correspondent Contact JOCK M WALKER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/08/1991
Decision Date 06/03/1991
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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