MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS— 510(k) K011831

Substantially Equivalent

Denver Biomedical, Inc.

FDA 510(k) clearance K011831 for MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS, Substantially Equivalent on 2001-06-28. Applicant: Denver Biomedical, Inc..

Clearance details

Applicant: Denver Biomedical, Inc.
Product code: Code DWM
Advisory panel: Cardiovascular
Date received: 2001-06-12
Decision date: 2001-06-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Golden, CO, US

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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.