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

Clearance details

Applicant

Argon Medical Devices, Inc.

Product code

Code DTK

Device class

Class 2

Regulation

21 CFR 870.3375

Advisory panel

Cardiovascular

Date received

2024-09-03

Decision date

2024-09-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Athens, TX, US

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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 →