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Sams 8000 Cardioplegia Monitor

by 3M Health Care, Sarns

510(k) K960916

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 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960916 Date4 Jun 1996ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3214-2011 FDA Unclassified (pre-2012) initiated 29 Aug 2011 on shared 510(k) K960916

    The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
DSJ
Device Class
Class II
Regulation
21 CFR Part 870.1100
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 Sams 8000 Cardioplegia Monitor is a blood pressure alarm device classified under 21 CFR 870.1100. It is designed for cardiovascular applications and was determined to be substantially equivalent to a predicate device through the FDA 510(k) clearance process.

The device is manufactured by 3M Health Care, Sarns, located at 6200 Jackson Rd., Ann Arbor, MI 48103. It received FDA 510(k) clearance on June 4, 1996, under K960916, and is compatible with the Sarns 8000 Modular Perfusion System.

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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 Sams 8000 Cardioplegia Monitor used for?

    The Sams 8000 Cardioplegia Monitor is designed for cardiovascular applications as a blood pressure alarm device, intended to monitor and alert during perfusion procedures where blood pressure monitoring is critical.

  • How was the Sams 8000 Cardioplegia Monitor cleared for market?

    The device was determined to be substantially equivalent to a predicate device and received FDA 510(k) clearance through the traditional process on June 4, 1996, under submission K960916.

  • Is the Sams 8000 Cardioplegia Monitor compatible with other systems?

    Yes, the Sams 8000 Cardioplegia Monitor is compatible with the Sarns 8000 Modular Perfusion System, allowing integration into existing perfusion setups for coordinated monitoring during cardiovascular surgery.