# K150109: Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International (A Subsidiary of Teleflex, Inc.)
- Decided: Jun 5, 2015 after 136 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K001901 (2000). 86 ancestors in all.
No later device cites it as a predicate yet.
6 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132133: CG+ Arrow Jacc Powered by Arrow VPS Stylet, Arrow International (Subsidiary of Teleflex Inc.) (2013) Summary page 4.
- K071538: Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter, Arrow International, Inc. (2007) Summary page 4.
- K140266: Nmi Picc IV, Navilyst Medical, Inc. (2014) Summary page 4.
- K080604: Pressure Injfectable Picc, Arrow International, Inc. (2008) Summary page 4.

## Indications for use
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology is indicated for short-term (up to 30-days) access to the central venous system for intravenous therapy, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of power injector equipment used with the Arrow Pressure Injectable JACC with Sustain Technology may not exceed 300 PSI. The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

Source page: https://510kreport.com/device/K150109
Methodology: https://510kreport.com/methodology