EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR— 510(k) K033250

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K033250 for EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR, Substantially Equivalent on 2003-12-30. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2003-10-07
Decision date: 2003-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.