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Brat 2 Autologus Blood Salvage System

by Cobe Cardiovascular, Inc.

510(k) K933625

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK933625 Date29 Dec 1993ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1070-05 FDA Unclassified (pre-2012) initiated 22 Jun 2005
    • Terminated Z-1071-05 FDA Unclassified (pre-2012) initiated 22 Jun 2005
    • Terminated Z-1069-05 FDA Unclassified (pre-2012) initiated 22 Jun 2005
    • Terminated Z-1072-05 FDA Unclassified (pre-2012) initiated 22 Jun 2005
    • Terminated Z-1073-05 FDA Unclassified (pre-2012) initiated 22 Jun 2005
    • Terminated Z-1074-05 FDA Unclassified (pre-2012) initiated 22 Jun 2005

    Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.

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  • Withdrawn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
CAC
Device Class
Class II
Regulation
21 CFR Part 868.5830
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Brat 2 Autologous Blood Salvage System is an apparatus for autotransfusion, used for the recovery and/or processing of autologous blood. It is a medical device classified under the regulation number 868.5830, with a product code of CAC, and is used in the medical specialty of Anesthesiology.

The system is supplied with a Crit-line Hematocrit Sampling System option to measure the hematocrit of the finished product in the reinfusion bag. The device has been assigned the FDA 510(k) number K933625, with a decision date of December 29, 1993, and is classified as substantially equivalent.

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Questions

AI-generated answers, 25 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 Brat 2 Autologous Blood Salvage System used for?

    The Brat 2 Autologous Blood Salvage System is used for the recovery and/or processing of autologous blood, specifically for autotransfusion in the medical specialty of Anesthesiology.

  • Is the Brat 2 Autologous Blood Salvage System supplied with any additional options?

    Yes, the system is supplied with a Crit-line Hematocrit Sampling System option to measure the hematocrit of the finished product in the reinfusion bag.

  • What is the regulatory classification of the Brat 2 Autologous Blood Salvage System?

    The device is classified under the regulation number 868.5830, with a product code of CAC, and has been assigned the FDA 510(k) number K933625.