VASSALLO GT EXT

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 Ext.

Pre-market Notification Details

Device IDK222631
510k NumberK222631
Device Name:VASSALLO GT EXT
ClassificationWire, Guide, Catheter
Applicant Filmecc Co. Ltd. 1703 Wakita-cho, Moriyama-ku Nagoya-shi,  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 Received2022-08-31
Decision Date2022-10-26

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