Embosphere Microspheres

Device, Vascular, For Promoting Embolization

Biosphere Medical, S.A.

The following data is part of a premarket notification filed by Biosphere Medical, S.a. with the FDA for Embosphere Microspheres.

Pre-market Notification Details

Device IDK181300
510k NumberK181300
Device Name:Embosphere Microspheres
ClassificationDevice, Vascular, For Promoting Embolization
Applicant Biosphere Medical, S.A. Parc Des Nations – Paris Nord 2, 383 Rue De La Belle Etoile Roissy En France,  FR 95700
ContactAlix Fonlladosa
CorrespondentRosene Amosse
Biosphere Medical, S.A. Parc Des Nations – Paris Nord 2, 383 Rue De La Belle Etoile Roissy En France,  FR 95700
Product CodeKRD  
Subsequent Product CodeHCG
Subsequent Product CodeNAJ
Subsequent Product CodeNOY
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-17
Decision Date2018-07-16
Summary:summary

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