OPTION ELITE VENA CAVA FILTER SYSTEM— 510(k) K133243

Substantially Equivalent

Rex Medical, L.P.

FDA 510(k) clearance K133243 for OPTION ELITE VENA CAVA FILTER SYSTEM, Substantially Equivalent on 2013-12-17. Applicant: Rex Medical, L.P..

Clearance details

Applicant: Rex Medical, L.P.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2013-10-22
Decision date: 2013-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.