510(k) K003964— TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B

Substantially Equivalent

Cordis Corp.

Clearance details

Applicant: Cordis Corp.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2000-12-22
Decision date: 2001-01-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Warren, NJ, US

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.