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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K151187
Device Name QuadraSphere Microspheres
Applicant
Biosphere Medical, S.A.
Parc Des Nations - Paris Nord 2
383 Rue De La Belle Etoile
Roissy-En-France,  FR 95700
Applicant Contact ALIX FONLLADOSA
Correspondent
Biosphere Medical, S.A.
Parc Des Nations - Paris Nord 2
383 Rue De La Belle Etoile
Roissy-En-France,  FR 95700
Correspondent Contact LIONEL EKEDI NGANDO
Regulation Number870.3300
Classification Product Code
KRD  
Subsequent Product Code
HCG  
Date Received05/04/2015
Decision Date 07/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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