CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B— 510(k) K023116

Unknown

Cordis Corp.

FDA 510(k) clearance K023116 for CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B, Unknown on 2002-10-18. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2002-09-19
Decision date: 2002-10-18
Decision: Unknown
Clearance type: Special
Location: Warren, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTK

product code DTK

Death: 208
Injury: 11,286
Malfunction: 3,002
Total: 14,496

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.