Aspira Pleural Drainage System— 510(k) K212696

Name: FDA 510(k) clearance K212696
Creator: U.S. Food and Drug Administration
Published: 2023-03-03

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K212696 for Aspira Pleural Drainage System, Substantially Equivalent on 2023-03-03. Applicant: Merit Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DWM
Device class: Class 2
Regulation: 21 CFR 870.5050
Advisory panel: Cardiovascular
Date received: 2021-08-25
Decision date: 2023-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWM

product code DWM

Death: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.