FDA Product Code
FDA Product Code NAJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3300
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233813 | Bearing nsPVA Express | Merit Medical Systems, Inc. | 2023-12-21 | Special | PDF ↗ |
| K173871 | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 2018-09-17 | Traditional | PDF ↗ |
| K133447 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES | Celonova Biosciences, Inc. | 2014-02-24 | Traditional | PDF ↗ |
| K130259 | BEARING NSPVA EMBOLIZATION PARTICLES | Merit Medical Systems, Inc. | 2013-06-07 | Traditional | PDF ↗ |
| K100663 | CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 | Boston Scientific Corporation | 2010-04-16 | Traditional | PDF ↗ |
| K081768 | COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES | Cook Incorporated | 2008-12-23 | Traditional | PDF ↗ |
| K030966 | CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER | Boston Scientific Corp | 2003-09-23 | Traditional | PDF ↗ |
| K021397 | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION | Biosphere Medical, Inc. | 2002-11-22 | Traditional | PDF ↗ |
Product code NAJ · Class II · Cardiovascular. Data: openFDA.