Torpedo Gelatin Foam

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 Torpedo Gelatin Foam.

Pre-market Notification Details

Device IDK192480
501k NumberK192480
Device Name:Torpedo Gelatin Foam
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
CorrespondentAlix Fonlladosa
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
501k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-10
Decision Date2019-11-21

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