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Traumafuse Perfusion Pressure Relief Valve

by The Traumafuse Co.

510(k) K894721

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 NumberK894721 Date20 Oct 1989ClearedStatusActive

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  • Withdrawn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
DWE
Device Class
Class II
Regulation
21 CFR Part 870.4390
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 Traumafuse Perfusion Pressure Relief Valve is a device used in cardiopulmonary bypass systems to relieve excess pressure in the perfusion circuit. It is classified as a Class II medical device under FDA regulation 870.4390 and is intended for use in cardiovascular applications.

The device received FDA 510(k) clearance (K894721) on October 20, 1989, and is manufactured by The Traumafuse Co. It is supplied as a non-sterile, reusable component for use in clinical settings requiring cardiopulmonary bypass support.

Other devices from The Traumafuse Co.

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 Traumafuse Perfusion Pressure Relief Valve used for?

    It is used in cardiopulmonary bypass systems to relieve excess pressure in the perfusion circuit, protecting the system and patient from overpressure during cardiovascular procedures.

  • Is the Traumafuse Perfusion Pressure Relief Valve sterile or non-sterile when supplied?

    The device is supplied as a non-sterile component, meaning it must be sterilized by the user before clinical use in accordance with their facility's reprocessing protocols.

  • Can the Traumafuse Perfusion Pressure Relief Valve be reused after cleaning?

    Yes, the device is designed as a reusable component, allowing for multiple uses after proper cleaning, disinfection, and sterilization between procedures.

  • What regulatory pathway was used for the Traumafuse Perfusion Pressure Relief Valve?

    The device received FDA 510(k) clearance under submission K894721, demonstrating substantial equivalence to a legally marketed predicate device.

  • What is the FDA product code and regulation number for the Traumafuse Perfusion Pressure Relief Valve?

    The device is classified under product code DWE and regulation number 870.4390, which covers tubing, pump, and cardiopulmonary bypass devices.