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C.A.T.S. Continuous Autotransfusion System

by Fresenius AG

510(k) K960006

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK960006 Date31 Jul 1996ClearedStatusActive

Recalls

4 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0341-2011 FDA Unclassified (pre-2012) initiated 29 Mar 2010
    • Terminated Z-0340-2011 FDA Unclassified (pre-2012) initiated 29 Mar 2010
    • Terminated Z-0342-2011 FDA Unclassified (pre-2012) initiated 29 Mar 2010

    Using AT1 Autotransfusion Set from specific batches in combination with the auto transfusion device CATS Continuous Autotransfusion has led to insufficient suction of shed blood from the collection reservoir. The results in the failure message "alarm blood flow" and the CATS device stops in a secure mode.

    • Terminated Z-0906-03 FDA Unclassified (pre-2012) initiated 21 Jan 2003

    Sterility may be compromised

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  • Withdrawn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

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