VASSALLO GT

Wire, Guide, Catheter

Filmecc Co., Ltd

The following data is part of a premarket notification filed by Filmecc Co., Ltd with the FDA for Vassallo Gt.

Pre-market Notification Details

Device IDK203533
510k NumberK203533
Device Name:VASSALLO GT
ClassificationWire, Guide, Catheter
Applicant Filmecc Co., Ltd 1703 Wakita-cho, Moriyama-ku Nagoya,  JP 463-0024
ContactToshiya Osawa
CorrespondentCandace Cederman
CardioMed Device Consultants, LLC 1783 Forest Drive, Suite 254 Annapolis,  MD  21401
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-02
Decision Date2021-04-21

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