# K031151: TS3 Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Global Blood Resources, LLC
- Decided: Jun 26, 2003 after 77 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- 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 Venous Reservoir Bag: named in the summary without a submission number
- (no number) Baxter 1/4" tubing: named in the summary without a submission number

## Indications for use
The TS3 Tubing Set serves as a fluid delivery pathway for anticoagulated whole blood from extracorporeal circuits to be delivered to and from a hemoconcentrator. The TS3 Tubing Set may be used in either of the following situations: a) As a conduit for conventional hemoconcentration during Cardiopulmonary Bypass surgery, or b) As a conduit for use with the HEMOBAGTMBlood Salvage Device as a hemoconcentration reservoir.

Source page: https://510kreport.com/device/K031151
Methodology: https://510kreport.com/methodology