FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW— 510(k) K012178

Name: FDA 510(k) clearance K012178
Creator: U.S. Food and Drug Administration
Published: 2001-07-23

Substantially Equivalent

Fresenius Hemotechnology, Inc.

FDA 510(k) clearance K012178 for FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW, Substantially Equivalent on 2001-07-23. Applicant: Fresenius Hemotechnology, Inc.. Device class: 2.

Clearance details

Applicant: Fresenius Hemotechnology, Inc.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 2001-07-12
Decision date: 2001-07-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.