Bearing nsPVA Express— 510(k) K233813
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K233813 for Bearing nsPVA Express, Substantially Equivalent on 2023-12-21. Applicant: Merit Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Code NAJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South Jordan, UT, US
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- K100663 — CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
- K081768 — COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
More clearances from Merit Medical Systems, Inc.
view allAdverse 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.