Super Sheath

Dilator, Vessel, For Percutaneous Catheterization


The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Super Sheath.

Pre-market Notification Details

Device IDK200379
510k NumberK200379
Device Name:Super Sheath
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant TOGO MEDIKIT CO., LTD. 17148-6 Aza Kamekawa, Oaza Hichiya Hyuga City,  JP 883-0062
ContactDaisuke Nagamizu
CorrespondentIzumi Maruo
MIC International 4-1-17 Hongo Bunkyo-ku,  JP 113-0033
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-18
Decision Date2020-03-19

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