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

Clearance details

Applicant

Rex Medical, L.P.

Product code

Code DTK

Device class

Class 2

Regulation

21 CFR 870.3375

Advisory panel

Cardiovascular

Date received

2013-10-22

Decision date

2013-12-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Great Neck, NY, US

• K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E)2024-09-10
• K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System2024-07-31
• K241507 — ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)2024-06-26
• K240257 — Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit2024-02-29
• K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT) +4 more2024-01-18

• K212351 — Revolution Peripheral Atherectomy System2021-12-15
• K191419 — Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire2019-09-12
• K173389 — Rex Medical Aspiration Pump2018-01-30
• K143405 — Option (TM) ELITE Vena Cava Filter 100cm System2015-04-16
• K141617 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM2014-11-14

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 →

• Z-0589-2026 — Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicatedClass II·Ongoing·Argon Medical Devices, Inc·20250912
• Z-2239-2023 — Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797Class II·Ongoing·Argon Medical Devices, Inc·20230608

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133243.