Product code NAJ
- Device name
- Agents, Embolic, For Treatment Of Uterine Fibroids
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.3300
- Review panel
- OB
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233813 | Bearing nsPVA Express™ | Merit Medical Systems, Inc. | 2023-12-21 |
| K173871 | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 2018-09-17 |
| K133447 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES | Celonova Biosciences, Inc. | 2014-02-24 |
| K130259 | BEARING NSPVA EMBOLIZATION PARTICLES | Merit Medical Systems, Inc. | 2013-06-07 |
| K100663 | CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 | Boston Scientific Corporation | 2010-04-16 |
| K081768 | COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES | Cook Incorporated | 2008-12-23 |
| K030966 | CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER | Boston Scientific Corp | 2003-09-23 |
| K021397 | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION | Biosphere Medical, Inc. | 2002-11-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810563021073 | Embozene Color Advance 75um Embozene 2mL Colored - US | Varian Medical Systems, Inc. | 2023-05-19 |
| 00810563021066 | Embozene Color Advance 40um Embozene 2mL Colored - US | Varian Medical Systems, Inc. | 2023-05-19 |
| 00191506011383 | Bead Block™ | BOSTON SCIENTIFIC CORPORATION | 2021-10-14 |
| 00191506011376 | Bead Block™ | BOSTON SCIENTIFIC CORPORATION | 2021-10-14 |
| 00191506011352 | Bead Block™ | BOSTON SCIENTIFIC CORPORATION | 2021-10-14 |
| 00191506011345 | Bead Block™ | BOSTON SCIENTIFIC CORPORATION | 2021-10-14 |
| 08714729942405 | Embozene® | BOSTON SCIENTIFIC CORPORATION | 2016-06-06 |
| 08714729944003 | Embozene® | BOSTON SCIENTIFIC CORPORATION | 2016-06-06 |
| 08714729943808 | Embozene® | BOSTON SCIENTIFIC CORPORATION | 2016-06-06 |
| 08714729943600 | Embozene® | BOSTON SCIENTIFIC CORPORATION | 2016-06-06 |
| 08714729943402 | Embozene® | BOSTON SCIENTIFIC CORPORATION | 2016-06-06 |
| 08714729943204 | Embozene® | BOSTON SCIENTIFIC CORPORATION | 2016-06-06 |
| 08714729943006 | Embozene® | BOSTON SCIENTIFIC CORPORATION | 2016-06-06 |
| 08714729942801 | Embozene® | BOSTON SCIENTIFIC CORPORATION | 2016-06-06 |
| 08714729942603 | Embozene® | BOSTON SCIENTIFIC CORPORATION | 2016-06-06 |
| 08714729942207 | Embozene® | BOSTON SCIENTIFIC CORPORATION | 2016-06-06 |
| 08714729743958 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729744085 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729744078 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729744061 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729744054 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729744047 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729744030 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729744023 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729744016 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729744009 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729743996 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729743989 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729743972 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729743965 | Contour™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |