CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT— 510(k) K000062

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K000062 for CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, Substantially Equivalent on 2000-07-07. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2000-01-10
Decision date: 2000-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
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.