# K012178: Fresenius C.a.T.S; Ati Autotransfusion Set; PSQ Plasma Sequestration Set; PSQ-DD Plasma Sequestration Direct Draw

- Pathway: 510(k) (Special)
- Applicant: Fresenius Hemotechnology, Inc.
- Decided: Jul 23, 2001 after 11 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fresenius C.A.T.S Continuous Autotransfusion System AT Autotransfusion Set: named in the summary without a submission number
- (no number) Fresenius C.A.T.S Continuous Autotransfusion System Plasma Sequestration Set: named in the summary without a submission number
- (no number) Fresenius C.A.T.S Continuous Autotransfusion System Plasma Sequestration Direct Draw Set: named in the summary without a submission number

## Recalls of this device
- Jan 21, 2003 · Not classified · Z-0906-03: Sterility may be compromised

## Indications for use
The Fresenius AT1 Autotransfusion Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. The Fresenius Plasma Sequestration Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Reich Plasma (PRP). The Fresenius Plasma Sequestration Direction Draw Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of biood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Reich Plasma (PRP).

Source page: https://510kreport.com/device/K012178
Methodology: https://510kreport.com/methodology