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Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm

by Inneuroco, Inc.

510(k) K173709

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK173709 Date26 Jan 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

Zenith Support is a clinician-facing device used in aortic-stent-grafts and venous-stents. It is designed to provide structural support during endovascular procedures involving stent grafts.

The device is available in three working lengths: 95 cm, 105 cm, and 115 cm, with an internal diameter of 0.074 inches and a nominal outer diameter of 0.086 inches. It is FDA 510(k) cleared under product code DQY, with decision code SESE and decision date 2018-01-26, and is supplied as a non-sterile, reusable device for use in clinical settings.

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Questions

AI-generated answers, 22 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 Zenith Support device used for?

    The Zenith Support device is used to provide structural support during endovascular procedures involving aortic-stent-grafts and venous-stents, helping maintain device position and stability during deployment.

  • What sizes is the Zenith Support available in?

    The Zenith Support is available in three working lengths: 95 cm, 105 cm, and 115 cm, all with a consistent internal diameter of 0.074 inches and nominal outer diameter of 0.086 inches.

  • Is the Zenith Support sterile or non-sterile, and is it reusable?

    The Zenith Support is supplied as a non-sterile device and is designed for reuse in clinical settings, requiring appropriate cleaning and sterilization by the user before each procedure.