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 ID: DEN160040
• Device Name: Embosphere Microspheres
• Classification: Agents, 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
• Contact: Alix Fonlladosa
• Product Code: NOY
• CFR Regulation Number: 876.5550 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device 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 Board: Gastroenterology/Urology
• Classification Advisory: Gastroenterology/Urology
• Type: Direct
• Date Received: 2016-08-05
• Decision Date: 2017-06-21
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884450299456	DEN160040	000
10884450299446	DEN160040	000