DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500— 510(k) K971753

Name: FDA 510(k) clearance K971753
Creator: U.S. Food and Drug Administration
Published: 1997-06-27

Unknown

Denver Biomaterials, Inc.

FDA 510(k) clearance K971753 for DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500, Unknown on 1997-06-27. Applicant: Denver Biomaterials, Inc.. Device class: 2.

Clearance details

Applicant: Denver Biomaterials, Inc.
Product code: Code DWM
Device class: Class 2
Regulation: 21 CFR 870.5050
Advisory panel: Cardiovascular
Date received: 1997-05-12
Decision date: 1997-06-27
Decision: Unknown
Clearance type: Traditional
Location: Golden, CO, 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.