Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular— 510(k) K150262

Substantially Equivalent

Volcano Corporation

FDA 510(k) clearance K150262 for Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular, Substantially Equivalent on 2015-04-03. Applicant: Volcano Corporation.

Clearance details

Applicant: Volcano Corporation
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2015-02-04
Decision date: 2015-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.