NAJ — Agents, Embolic, For Treatment Of Uterine Fibroids Class II
FDA Device Classification
Classification Details
- Product Code
- NAJ
- Device Class
- Class II
- Regulation Number
- 870.3300
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K233813 | merit medical systems | Bearing nsPVA Express | December 21, 2023 |
| K173871 | suzhou hengrui callisyn biomedical co | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | September 17, 2018 |
| K133447 | celonova biosciences | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES | February 24, 2014 |
| K130259 | merit medical systems | BEARING NSPVA EMBOLIZATION PARTICLES | June 7, 2013 |
| K100663 | boston scientific corporation | CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 | April 16, 2010 |
| K081768 | cook incorporated | COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES | December 23, 2008 |
| K030966 | boston scientific | CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER | September 23, 2003 |
| K021397 | biosphere medical | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMB | November 22, 2002 |