EmboCube Embolization Gelatin

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 Embocube Embolization Gelatin.

Pre-market Notification Details

Device IDK183120
510k NumberK183120
Device Name:EmboCube Embolization Gelatin
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  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-09
Decision Date2019-08-06

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