Search Results
Found 2 results
510(k) Data Aggregation
K Number
K971274Device Name
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET
Manufacturer
FRESENIUS AG
Date Cleared
1997-06-13
(67 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
FRESENIUS AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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).
Device Description
The Fresenius C.A.T.S is a continuous autotransfusion system working on the principle of a continuous flow centrifuge. In this continuous system, the blood to be processed passes through a separation chamber that can be divided into several compartments in which different steps of the autotransfusion process (i.e; plasma separation, resuspension with saline and reconcentration) are performed simultaneously, creating a continuous flow of blood through the system. The C.A.T.S device is comprised of two major components:
Reusable Autotransfusion Device: The C.A.T.S machine is an electromechanical a) microprocessor controlled device which incorporate the following major system components: the user display and function keys, centrifuge housing, centrifuge rotors; blood, packed red cell (PRC) and saline roller pumps; blood, saline and PRC sensors; leakage detector, and power supply unit. Additionally, the system includes the electronic components and system software which control and monitor the blood processing procedure.
b) Disposable AT1 Autotransfusion Set: This disposable set incorporates the continuous washing chamber, adapters for mounting the set into the C.A.T.S device, blood inlet line with stepped adapter, pump tubing, fluid lines; and the waste and reinfusion bags.
In order to perform plasma sequestration procedures a second disposable set is necessary:
c) PSQ Set: a single use, disposable set, includes bags for collection of plasma and platelet concentrates. Additionally, the PSQ Set includes lines/connections for connection to the whole blood bag and connection to the C.A.T.S AT 1 Autotransfusion Set.
Ask a Question
K Number
K960006Device Name
C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM
Manufacturer
FRESENIUS AG
Date Cleared
1996-07-31
(211 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
FRESENIUS AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1