PLEURX PLEURAL CATHETER KIT, MODEL 50-7000— 510(k) K052436

Substantially Equivalent

Denver Biomedical, Inc.

FDA 510(k) clearance K052436 for PLEURX PLEURAL CATHETER KIT, MODEL 50-7000, Substantially Equivalent on 2005-10-06. Applicant: Denver Biomedical, Inc..

Clearance details

Applicant: Denver Biomedical, Inc.
Product code: Code DWM
Advisory panel: Cardiovascular
Date received: 2005-09-06
Decision date: 2005-10-06
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.