NAJ

Agents, Embolic, For Treatment Of Uterine Fibroids

Product code: NAJ
Device name: Agents, Embolic, For Treatment Of Uterine Fibroids
Device class: Class 2
21 CFR: 21 CFR 870.3300
Medical specialty: Cardiovascular
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (last 3 years): 1
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 8 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-12-21.

Number	Decision date	Applicant	Device name	Summary
K233813	2023-12-21	Merit Medical Systems, Inc.	Bearing nsPVA Express	PDF

1 summaries are archived here for direct download.

Official FDA classification page: NAJ

Classification and pathway per current FDA publications. Data from openFDA (CC0).