# K233813: Bearing nsPVA Express™

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Dec 21, 2023 after 21 days
- Product code: NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K961923 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130259: Bearing Nspva Embolization Particles, Merit Medical Systems, Inc. (2013) Summary page 5.

## Indications for use
Bearing nsPVA Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

Source page: https://510kreport.com/device/K233813
Methodology: https://510kreport.com/methodology