CRUX VENA CAVA FILTER SYSTEM— 510(k) K122585

Substantially Equivalent

Crux Biomedical

FDA 510(k) clearance K122585 for CRUX VENA CAVA FILTER SYSTEM, Substantially Equivalent on 2013-01-17. Applicant: Crux Biomedical.

Clearance details

Applicant: Crux Biomedical
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2012-08-24
Decision date: 2013-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Menlo Park, 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.