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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 K050114
Device Name SUPERCATH Z3V
Applicant
TOGO MEDIKIT CO., LTD.
17148-6 AZA KAMEKAWA
OAZA HICHIYA
HYUGA CITY, MIYAZAKI PREF.,  JP 883-0062
Applicant Contact KOZO NAGAYAMAB
Correspondent
TOGO MEDIKIT CO., LTD.
17148-6 AZA KAMEKAWA
OAZA HICHIYA
HYUGA CITY, MIYAZAKI PREF.,  JP 883-0062
Correspondent Contact KOZO NAGAYAMAB
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/18/2005
Decision Date 06/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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