SUPERCATH A.V. FISTULA

Needle, Fistula

TOGO MEDIKIT CO., LTD.

The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Supercath A.v. Fistula.

Pre-market Notification Details

Device IDK854773
510k NumberK854773
Device Name:SUPERCATH A.V. FISTULA
ClassificationNeedle, Fistula
Applicant TOGO MEDIKIT CO., LTD. SHOEI-SURVGADAI BLDG 1-2 KANDA-SURUGADAI 3 CHOME Chiyoda-ku Tokyo101 Japan,  JP
ContactHiroaki Nakajima
CorrespondentHiroaki Nakajima
TOGO MEDIKIT CO., LTD. SHOEI-SURVGADAI BLDG 1-2 KANDA-SURUGADAI 3 CHOME Chiyoda-ku Tokyo101 Japan,  JP
Product CodeFIE  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-11-29
Decision Date1986-04-08

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