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Sentry IVC Filter

by Novate Medical, Ltd. 3 variants

510(k) K173236

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 NumberK173236 Date22 Feb 2018ClearedStatusActive

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  • Withdrawn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
FDA applicant
Novate Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.3375
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Sentry IVC Filter is a bioconvertible intravascular device designed for temporary placement in the inferior vena cava. It functions as a mechanical barrier to capture emboli, thereby reducing the risk of pulmonary embolism. Classified as a Class 2 device under product code DTK, it adheres to regulatory standards for cardiovascular filters. The device is intended for percutaneous insertion and removal, ensuring minimal invasiveness during use.

This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K173236) and falls under the jurisdiction of the Cardiovascular Advisory Committee. The Sentry IVC Filter is compatible with MRI environments, as indicated by its regulatory classification. Storage and handling must adhere to sterile medical device protocols to maintain integrity before deployment. Authorisations include FDA clearance through the traditional 510(k) pathway, with no third-party involvement.

Other devices from Novate Medical, Ltd.

Questions

AI-generated answers, 1 Oct 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 Sentry IVC Filter designed for?

    The Sentry IVC Filter is a bioconvertible intravascular device intended for temporary placement in the inferior vena cava. It acts as a mechanical barrier to capture emboli, helping to lower the risk of pulmonary embolism. The design ensures percutaneous insertion and removal, minimizing invasiveness during use.

  • How is the Sentry IVC Filter supplied and is it reusable?

    The Sentry IVC Filter is supplied sterile and is explicitly intended for single-use only. This ensures patient safety and compliance with medical device sterility protocols before deployment.

  • Can the Sentry IVC Filter be used in MRI environments?

    Yes, the Sentry IVC Filter is compatible with MRI environments. This compatibility is reflected in its regulatory classification and design specifications, allowing for safe use in imaging scenarios where MRI is required.

  • What regulatory pathway does the Sentry IVC Filter follow?

    The Sentry IVC Filter has received FDA clearance through the traditional 510(k) pathway, specifically under clearance number K173236. It is classified as a Class 2 device under product code DTK and falls under the jurisdiction of the Cardiovascular Advisory Committee.

  • How should the Sentry IVC Filter be stored before use?

    The Sentry IVC Filter must be stored and handled according to sterile medical device protocols to maintain its integrity before deployment. Proper storage ensures the device remains uncontaminated and ready for use when needed.