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IBC Vent Valve, Model 1400

by International Biophysics Corp. 510(k)

Active United States

510(k) K992964

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992964 Date19 Nov 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MNJ
Device Class
Class II
Regulation
21 CFR Part 870.4400
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The IBC Vent Valve, Model 1400 is a pressure relief valve designed for cardiopulmonary bypass applications. It operates by opening when a predetermined vacuum level is reached in the reservoir, functioning optimally when the pump operates at a slow rate.

This device is supplied by International Biophysics Corp. and is classified as a Class II medical device under product code MNJ with special controls. The IBC Vent Valve is substantially equivalent to the American Omni Vent Valve and received FDA 510(k) clearance on November 19, 1999 (K992964).

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Questions

AI-generated answers, 1 Oct 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 IBC Vent Valve Model 1400 used for?

    The IBC Vent Valve Model 1400 is a pressure relief valve specifically designed for cardiopulmonary bypass applications. It opens when a predetermined vacuum level is reached in the reservoir and functions optimally when the pump operates at a slow rate.

  • How is the IBC Vent Valve Model 1400 supplied?

    The IBC Vent Valve Model 1400 is supplied by International Biophysics Corp. It is classified as a Class II medical device under product code MNJ with special controls.

  • What is the regulatory status of the IBC Vent Valve Model 1400?

    The IBC Vent Valve Model 1400 received FDA 510(k) clearance on November 19, 1999 (K992964). It is substantially equivalent to the American Omni Vent Valve and is classified under product code MNJ with special controls.

  • Is the IBC Vent Valve Model 1400 reusable or single-use?

    The device data does not specify whether the IBC Vent Valve Model 1400 is designed for single-use or multiple uses. For proper usage instructions and reprocessing information, please refer to the manufacturer's documentation or contact International Biophysics Corp.