OPTION VENA CAVA FILTER— 510(k) K081410

Substantially Equivalent

Rex Medical

FDA 510(k) clearance K081410 for OPTION VENA CAVA FILTER, Substantially Equivalent on 2009-06-04. Applicant: Rex Medical.

Clearance details

Applicant: Rex Medical
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2008-05-20
Decision date: 2009-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northborough, MA, 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.