# K161765: CG+ Arrow JACC

- Pathway: 510(k) (Special)
- Applicant: Arrow International, Inc. (Subsidiary of Teleflex
- Decided: Sep 6, 2016 after 71 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
Longest line of descent: 13 generations back to K001901 (2000). 65 ancestors in all.
No later device cites it as a predicate yet.
7 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153423: CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC, Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (2016) Summary page 4.

## Indications for use
The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) is indicated for short-term (<30 days) or long-term (>30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub. Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

Source page: https://510kreport.com/device/K161765
Methodology: https://510kreport.com/methodology