Product code NAJ— Cardiovascular
BEARING NSPVA EMBOLIZATION PARTICLES
- Classification name
- Agents, Embolic, For Treatment Of Uterine Fibroids
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code NAJ
FDA has cleared devices under product code NAJ between 2002 and 2023, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2018
- 2014
- 2013
- 2010
- 2008
- 2003
- 2002
Top applicants under product code NAJ
Adverse events under product code NAJ
product code NAJ- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NAJ
- K233813 — Bearing nsPVA Express
- K173871 — CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
- K133447 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
- K130259 — BEARING NSPVA EMBOLIZATION PARTICLES
- K100663 — CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
- K081768 — COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
- K030966 — CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
- K021397 — EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION
Data sourced from openFDA. This site is unofficial and independent of the FDA.