VenSure Balloon Device, VenSure Nav Balloon Device

Instrument, Ent Manual Surgical

Fiagon GmbH

The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Vensure Balloon Device, Vensure Nav Balloon Device.

Pre-market Notification Details

Device IDK201472
510k NumberK201472
Device Name:VenSure Balloon Device, VenSure Nav Balloon Device
ClassificationInstrument, Ent Manual Surgical
Applicant Fiagon GmbH Neuendorfstr. 23b Hennigsdorf,  DE 16761
ContactDirk Mucha
CorrespondentDirk Mucha
Fiagon GmbH Neuendorfstr. 23b Hennigsdorf,  DE 16761
Product CodeLRC  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-03
Decision Date2020-08-26

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