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Cobe Vacuum Relief Check Valve

by Cobe Cardiovascular, Inc.

510(k) K982406

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK982406 Date7 Oct 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MJJ
Device Class
Class II
Regulation
21 CFR Part 870.4400
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 Cobe Vacuum Relief Check Valve is a cardiopulmonary bypass check valve designed for in-line use. It functions to prevent the buildup of excessive vacuum pressure during suctioning from the heart or surgical field and helps prevent the inadvertent flow of air into the heart.

This device is regulated as a Class II medical device under product code MJJ and regulation number 870.4400. It received FDA 510(k) clearance on October 7, 1998, under submission K982406.

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