# K973378: C.a.T.S Continuous Autotransfusion System Model 900500 1, AT1 Autotransfusion Set Model 900 510 1, PSQ Set (DD) Model 61

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius USA, Inc.
- Decided: Nov 3, 1997 after 56 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: none
- 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) Medtronic Sequestra 1000: named in the summary without a submission number
- (no number) Haemonetics CellSaver 5 Autotransfusion System: named in the summary without a submission number

## Indications for use
The C.A.T.S (Continuous Autotransfusion System) by Fresenius is an autotransfusion device indicated 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 Rich Plasma (PRP).

Source page: https://510kreport.com/device/K973378
Methodology: https://510kreport.com/methodology