3T VESSEL CANNULAS— 510(k) K020768

Substantially Equivalent

3t Medical Systems, LLC

FDA 510(k) clearance K020768 for 3T VESSEL CANNULAS, Substantially Equivalent on 2002-08-23. Applicant: 3t Medical Systems, LLC.

Clearance details

Applicant: 3t Medical Systems, LLC
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2002-03-07
Decision date: 2002-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conifer, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.