FMD Peripheral Guide Wires F-14 And F-18, FMD Guide Wire Extension F-14 EXT

Wire, Guide, Catheter

FMD Co., Ltd.

The following data is part of a premarket notification filed by Fmd Co., Ltd. with the FDA for Fmd Peripheral Guide Wires F-14 And F-18, Fmd Guide Wire Extension F-14 Ext.

Pre-market Notification Details

Device IDK212268
510k NumberK212268
Device Name:FMD Peripheral Guide Wires F-14 And F-18, FMD Guide Wire Extension F-14 EXT
ClassificationWire, Guide, Catheter
Applicant FMD Co., Ltd. 1-57-7 Sasazuka Shibuya-ku,  JP 151-0073
ContactTakashi Higashikubo
CorrespondentMaximilian Bynum
FMD Co., Ltd. 2777 Yulupa Ave. Ste 303 Santa Rosa,  CA  95405 -8584
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-20
Decision Date2022-05-27

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