# K092040: Pherocious 10.5 FR (24 CM, 28 CM and 32 CM), Models 430102440, 430102840, 430103240

- Pathway: 510(k) (Traditional)
- Applicant: R4 Vascular, Inc.
- Decided: Nov 18, 2009 after 139 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- 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) Hickman Long-Term Central Venous Catheter, Bard Hickman TriFusion: named in the summary without a submission number
- (no number) ZeusTM CT PICC: named in the summary without a submission number

## Indications for use
The r4 PherociousTM apheresis triple lumen catheter is designed for short and long term (>30 days) apheresis, intravenous infusion, blood sampling and CECT via the jugular veins or subclavian vein. The maximum recommended flow rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.

Source page: https://510kreport.com/device/K092040
Methodology: https://510kreport.com/methodology