C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61

About This 510(k) Submission

K973378 is an FDA 510(k) clearance for the C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on November 3, 1997, 56 days after receiving the submission on September 8, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.