STERILE CHEST TUBE— 510(k) K913733

Name: FDA 510(k) clearance K913733
Creator: U.S. Food and Drug Administration
Published: 1991-10-08

Substantially Equivalent

Vascular Products, Inc.

FDA 510(k) clearance K913733 for STERILE CHEST TUBE, Substantially Equivalent on 1991-10-08. Applicant: Vascular Products, Inc.. Device class: 1.

Clearance details

Applicant: Vascular Products, Inc.
Product code: Code GBW
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1991-08-20
Decision date: 1991-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Florida, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GBW

product code GBW

Death: 6
Total: 6

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.