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Sentry IVC Filter

by Novate Medical, Ltd. 3 variants

510(k) K162875

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 NumberK162875 Date17 Feb 2017ClearedStatusActive

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  • Withdrawn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, 19 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 Sentry IVC Filter is a Filter, Intravascular, Cardiovascular device designed for percutaneous placement in the inferior vena cava. It is intended to prevent recurrent pulmonary embolism in patients with a transient high risk of pulmonary embolism (PE). The device is classified as a Class II medical device under FDA regulations (product code DTK).

The Sentry IVC Filter is supplied as a sterile, single-use device and is intended for use in interventional radiology or cardiology settings. It is manufactured by Novate Medical, Ltd. (Galway, Ireland) and has received FDA 510(k) clearance under the traditional review pathway. No additional regulatory markings (e.g., MRI safety, reusable status) are specified in the available data.

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