Bearing nsPVA Express™— 510(k) K233813

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K233813 for Bearing nsPVA Express™, Substantially Equivalent on 2023-12-21. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant
Merit Medical Systems, Inc.
Product code
Code NAJ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
South Jordan, UT, US
Download summary PDFView on FDA.gov ↗

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.