# K042473: Cobe Angel Whole Blood Separation System

- Pathway: 510(k) (Abbreviated)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Nov 19, 2004 after 67 days
- Product code: JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991430 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021902: Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet Separator Deisposable Kit, MKT300, Medtronic Vascular (2002) Summary page 1.

## Indications for use
The COBE® Angel Whole Blood Separation System is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.

Source page: https://510kreport.com/device/K042473
Methodology: https://510kreport.com/methodology