K233813
- 510(k) number
- K233813
- Device name
- Bearing nsPVA Express
- Applicant
- Merit Medical Systems, Inc. UT · US
- Product code
- NAJ — Agents, Embolic, For Treatment Of Uterine Fibroids
- Decision date
- 2023-12-21
- Date received
- 2023-11-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K233813.pdf
Official FDA record: K233813
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.