FDA 510(k) Applications for Medical Device Product Code "NAJ"
(Agents,Embolic,For Treatment Of Uterine Fibroids)

FDA 510(k) Number Applicant Device Name Decision Date
K021397 BIOSPHERE MEDICAL, INC. EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION 11/22/2002
K030966 BOSTON SCIENTIFIC CORP. CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER 09/23/2003
K100663 Boston Scientific Corporation CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 04/16/2010
K133447 CELONOVA BIOSCIENCES, INC. EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES 02/24/2014
K081768 COOK INCORPORATED COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES 12/23/2008
K130259 MERIT MEDICAL SYSTEMS, INC. BEARING NSPVA EMBOLIZATION PARTICLES 06/07/2013
K173871 Suzhou Hengrui Callisyn Biomedical Co., Ltd. CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres 09/17/2018


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