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

Substantially Equivalent

Fresenius Hemotechnology, Inc.

Clearance details

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

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.