510(k) K072697— 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES

Substantially Equivalent

3t Medical Systems, LLC

Clearance details

Applicant: 3t Medical Systems, LLC
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2007-09-24
Decision date: 2007-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conifer, CO, US

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.