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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 K112290
Device Name SUPERCATH Z3V
Applicant
Togo Medikit Co., Ltd.
4-1-17 Hongo
Bunkyo-Ku, Tokyo,  JP 113-0033
Applicant Contact FUMIAKI KANAI
Correspondent
Togo Medikit Co., Ltd.
4-1-17 Hongo
Bunkyo-Ku, Tokyo,  JP 113-0033
Correspondent Contact FUMIAKI KANAI
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/09/2011
Decision Date 04/16/2012
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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