Aspira Pleural Drainage System— 510(k) K212696
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K212696 for Aspira Pleural Drainage System, Substantially Equivalent on 2023-03-03. Applicant: Merit Medical Systems, Inc..
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Code DWM
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
Adverse events under product code DWM
product code DWM- Death
- 8
- Total
- 8
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.