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 |
| K233813 | Merit Medical Systems, Inc. | Bearing nsPVA ExpressÖ | 12/21/2023 |
| K173871 | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | 09/17/2018 |
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