Skip to content

Schneider Sidekick Monorail Y-Connector

by Schneider Intl., Ltd.

510(k) K897082

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 · Traditional NumberK897082 Date6 Mar 1990ClearedStatusActive

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  • Withdrawn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, 21 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 Schneider Sidekick Monorail Y-Connector is a Class 2 medical device classified under product code DQY. It is a cardiovascular device, substantially equivalent to other devices. The device is manufactured by Schneider Intl., Ltd.

The Schneider Sidekick Monorail Y-Connector is supplied with FDA 510K authorization, specifically clearance number K897082. It was cleared through the Traditional 510K pathway on March 6, 1990, after a 76-day review.

Other devices from Schneider Intl., Ltd.

See all devices from Schneider Intl., Ltd. →

Questions

AI-generated answers, 21 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 Schneider Sidekick Monorail Y-Connector used for?

    The Schneider Sidekick Monorail Y-Connector is used in cardiovascular applications, as classified under product code DQY.

  • Is the Schneider Sidekick Monorail Y-Connector supplied sterile?

    The device data does not specify sterility, contact the manufacturer for more information on packaging and sterilization.

  • What regulatory pathway was used for clearance?

    The Schneider Sidekick Monorail Y-Connector was cleared through the Traditional 510K pathway on March 6, 1990.