Optease Vena Cava Filter and Optease Retrieval Cathteter

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K140286 ↗

FDA Product Code

DTK

Device Class

Class II

Regulation

21 CFR Part 870.3375

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Outback Ltd Re-Entry Catheter, Model: OTB42120

  Class II

  FDA 510(k) K083814 Active Cleared 13 Jan 2009

• OUTBACK Elite Re-Entry Catheter

  Class II

  FDA 510(k) K150836 Active Cleared 29 Apr 2015

• Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping Tools, Cordis Introducer Tube

  Class II

  FDA 510(k) K992755 Active Cleared 15 Sep 1999

• Optease Vena Cava Filter and Retrieval Catheter

  Class II

  FDA 510(k) K091077 Active Cleared 4 Feb 2010

• Angioguard Xp Emboli Capture Guidewire and Angioguard Rx Emboli Capture Guidewire

  Class II

  FDA 510(k) K062531 Active Cleared 22 Sep 2006

• Adroit Guiding Catheter

  Class II

  FDA 510(k) K131225 Active Cleared 29 May 2013

See all devices from Cordis Corp., A Johnson & Johnson Co. →

• What is the OptEase Vena Cava Filter designed to do?

  The OptEase Vena Cava Filter is an intravascular device placed within the inferior vena cava to prevent pulmonary embolism by trapping venous thrombi. It is specifically engineered as a retrievable filter, allowing for removal once the patient’s risk of embolism has resolved, typically within up to 12 days after implantation. This design minimizes complications associated with long-term placement while providing temporary protection for patients at risk of deep vein thrombosis.

• How is the OptEase Vena Cava Filter supplied, and what access sites can it use?

  The OptEase Vena Cava Filter is supplied as a complete kit, including a 90 cm catheter. This catheter is designed for delivery through multiple venous access sites, such as the femoral, jugular, or antecubital veins. The kit ensures all necessary components are available for immediate use in a clinical setting like a catheterization lab or operating room.

• Is the OptEase Vena Cava Filter intended for single-use or reuse?

  The OptEase Vena Cava Filter is intended for single-use only. This design ensures sterility and safety, as it requires sterile handling in a controlled clinical environment. Reuse is not recommended or supported by the manufacturer to maintain efficacy and prevent contamination.

• What are the key considerations for storage of the OptEase Vena Cava Filter kit?

  The OptEase Vena Cava Filter kit must be stored in a manner that preserves its sterility and integrity. It should be kept in its original packaging, protected from moisture, dust, and extreme temperatures. The manufacturer’s instructions for storage conditions should be followed to ensure the device remains functional and safe for use when needed.

• What regulatory pathway does the OptEase Vena Cava Filter follow?

  The OptEase Vena Cava Filter has received FDA 510(k) clearance under the Special 510(k) pathway. This pathway is used for devices that are substantially equivalent to a predicate device already on the market. The clearance was granted by the FDA’s Cardiovascular (CV) advisory committee, adhering to regulatory standards for cardiovascular devices classified under Device Type Code (DTK).