Embosphere Microspheres

Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Biosphere Medical S.A.

The following data is part of a De Novo classification by Biosphere Medical S.a. with the FDA for Embosphere Microspheres.

Pre-market Notification Details

DeNovo IDDEN160040
Device Name:Embosphere Microspheres
ClassificationAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Applicant Biosphere Medical S.A. a Wholly Owned Subsidiary Of Merit Medical Systems Inc. parc Des Nations-paris Nord 2 383 Rue De La Belle Etoile,  FR 95700
ContactAlix Fonlladosa
Product CodeNOY  
CFR Regulation Number876.5550 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
TypeDirect
Date Received2016-08-05
Decision Date2017-06-21
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884450299456 DEN160040 000
10884450299446 DEN160040 000

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