Simon Nitinol Filter

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

510(k) Number

K894703 ↗

FDA Product Code

DTK

Device Class

Class II

Regulation

21 CFR Part 870.3375

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Simon Nitinol Filter/Straight Line System

  Class II

  FDA 510(k) K963014 Active Cleared 18 Nov 1996

• Simon Nitinol Filter, Modification

  Class II

  FDA 510(k) K912144 Active Cleared 17 Oct 1991

• Simon Nitinol Filter

  Class II

  FDA 510(k) K940489 Active Cleared 9 Aug 1994

• Simon Nitinol Filter System

  Class II

  FDA 510(k) K963016 Active Cleared 18 Nov 1996

• Simon Nitinol Filter/Straight Line System

  Class II

  FDA 510(k) K970099 Active Cleared 16 Apr 1997

• Simon Nitinol Filter

  Class II

  FDA 510(k) K944353 Active Cleared 28 Apr 1995

• What is the Simon Nitinol Filter designed to prevent?

  The Simon Nitinol Filter is specifically designed to prevent emboli—such as thrombi or other particulate matter—from traveling through the venous system to the pulmonary arteries. By deploying the filter within the inferior vena cava or other large veins, it physically captures these emboli, significantly lowering the risk of pulmonary embolism. This is particularly critical for patients at high risk of venous thromboembolism complications.

• How is the Simon Nitinol Filter supplied and prepared for use?

  The Simon Nitinol Filter is supplied as a sterile, single-use device, meaning each unit is intended for one-time clinical use only. Prior to deployment, strict sterile techniques must be followed to ensure no contamination occurs. The device is delivered in a sterile packaging designed for medical professionals, and it must be handled according to the manufacturer’s instructions to maintain sterility until deployment via catheterization.

• Is the Simon Nitinol Filter reusable, or is it intended for one-time use?

  The Simon Nitinol Filter is explicitly designed for single-use only. This is a standard practice for intravascular devices to ensure patient safety, as reuse could compromise sterility and integrity. After deployment, the filter remains permanently in place within the patient’s vasculature, so no retrieval or reuse is required or permitted.

• Can the Simon Nitinol Filter be used with MRI imaging?

  No, the Simon Nitinol Filter is not MRI-safe. This means it should not be used in patients who require MRI imaging, as the magnetic fields could interact with the nitinol alloy, potentially causing harm or interference. Clinicians must ensure alternative imaging modalities are used if MRI is needed post-deployment, and patients should be informed of this limitation.

• What regulatory approval does the Simon Nitinol Filter hold, and how is it classified?

  The Simon Nitinol Filter holds FDA 510(k) clearance under the reference number K894703, demonstrating it is classified as substantially equivalent to a predicate device. It falls under the regulatory classification DTK and the product code 870.3375, which categorizes it as an intravascular filter for cardiovascular use. This clearance ensures it meets U.S. safety and effectiveness standards for its intended purpose.