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Conducer Cardioplegia Set Sith MP4

by 3M Health Care, Ltd.

510(k) K922992

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 · Traditional NumberK922992 Date18 Sep 1992ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0160-2015 FDA Class II initiated 1 Mar 2011

    Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line

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  • Withdrawn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

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