Option (TM) ELITE Vena Cava Filter 100cm System— 510(k) K143405

Substantially Equivalent

Rex Medical, L.P.

FDA 510(k) clearance K143405 for Option (TM) ELITE Vena Cava Filter 100cm System, Substantially Equivalent on 2015-04-16. Applicant: Rex Medical, L.P..

Clearance details

Applicant: Rex Medical, L.P.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2014-11-28
Decision date: 2015-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conshohocken, PA, 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.