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Fresenius C.A.T.S; Ati Autotransfusion Set; Psq Plasma Sequestration Set; Psq-Dd Plasma Sequestration Direct Draw

by Fresenius Hemotechnology, Inc.

510(k) K012178

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 · Special NumberK012178 Date23 Jul 2001ClearedStatusActive

Recalls

1 recall · FDA

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  • Withdrawn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

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