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Tubing Pack

by Medtronic, Inc. 2 variants

510(k) K171308

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK171308 Date2 Jun 2017ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0535-2018 FDA Class II initiated 3 Jan 2018

    Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.

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  • Withdrawn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
DWF
Device class
Class II
Regulation
21 CFR Part 870.4210
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 Tubing Pack is a medical device classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass. It is designed for use in cardiovascular procedures, specifically in cardiopulmonary bypass systems.

The Tubing Pack is supplied by Medtronic, Inc. and is authorized under FDA 510K clearance. It is a Class II device and is part of the DWF product code category. The device is manufactured in facilities located in Kerkrade, The Netherlands and Tijuana, Mexico.

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