Option ELITE Vena Cava Filter System (352506070E 352506100E)— 510(k) K242612

Substantially Equivalent

Argon Medical Devices, Inc.

FDA 510(k) clearance K242612 for Option ELITE Vena Cava Filter System (352506070E 352506100E), Substantially Equivalent on 2024-09-10. Applicant: Argon Medical Devices, Inc..

Clearance details

Applicant: Argon Medical Devices, Inc.
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2024-09-03
Decision date: 2024-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Athens, TX, 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.