CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F— 510(k) K034050

Substantially Equivalent

Cordis Corporation

FDA 510(k) clearance K034050 for CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F, Substantially Equivalent on 2004-03-22. Applicant: Cordis Corporation.

Clearance details

Applicant: Cordis Corporation
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2003-12-30
Decision date: 2004-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warren, NJ, US

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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.