Skip to content

Simon Nitinol Filter, Modification

by Nitinol Medical Technologies, Inc.

510(k) K912144

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK912144 Date17 Oct 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DTK
Device Class
Class II
Regulation
21 CFR Part 870.3375
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Simon Nitinol Filter, Modification is an intravascular cardiovascular filter designed to capture and remove emboli from the bloodstream. It is constructed from nitinol, a shape memory alloy, and is intended for use in the vena cava to prevent pulmonary embolism.

This device is supplied as a single-use, sterile product and is available in various sizes as specified by the manufacturer. It is MRI conditional and has received FDA 510(k) clearance as substantially equivalent under product code DTK, regulation number 870.3375.

Other devices from Nitinol Medical Technologies, Inc.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Simon Nitinol Filter Modification used for?

    The Simon Nitinol Filter Modification is an intravascular cardiovascular filter designed to capture and remove emboli from the bloodstream, specifically intended for use in the vena cava to prevent pulmonary embolism.

  • Is the Simon Nitinol Filter Modification reusable or single-use?

    The Simon Nitinol Filter Modification is supplied as a single-use, sterile product and should not be reused for patient safety and regulatory compliance reasons.

  • What sizes are available for the Simon Nitinol Filter Modification?

    The Simon Nitinol Filter Modification is available in various sizes as specified by the manufacturer, allowing for appropriate selection based on patient anatomy and clinical requirements.

  • What is the regulatory status of the Simon Nitinol Filter Modification?

    The Simon Nitinol Filter Modification has received FDA 510(k) clearance as substantially equivalent under product code DTK, regulation number 870.3375, and is MRI conditional.