# K132133: CG+ Arrow Jacc Powered by Arrow VPS Stylet

- Pathway: 510(k) (Special)
- Applicant: Arrow International (Subsidiary of Teleflex Inc.)
- Decided: Sep 26, 2013 after 77 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 63 ancestors in all.
3 later devices descend from it; 2 cite it directly.
7 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103255: Vascular Positioning System TM (VPS TM System) Stylet, Vasonova, Inc. (2011) Summary page 1.
- K121501: Arrow Jugular Axillo-Subclavian Central Catheter (Jacc), Arrow International (Subsidiary of Teleflex Inc.) (2012) Summary page 1.

## Most influential descendants
- K153423: CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC (2016), 1 descendant of its own
- K161765: CG+ Arrow JACC (2016), 0 descendants of its own
- K150109: Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology (2015), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2379-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Apr 23, 2019 · Class II · Z-1816-2019: Lidstock states the incorrect expiration date for the product
- Apr 23, 2019 · Class II · Z-1817-2019: Lidstock states the incorrect expiration date for the product
- Apr 23, 2019 · Class II · Z-1815-2019: Lidstock states the incorrect expiration date for the product
- Apr 23, 2019 · Class II · Z-1806-2019: Lidstock states the incorrect expiration date for the product
- Apr 23, 2019 · Class II · Z-1814-2019: Lidstock states the incorrect expiration date for the product
- Apr 23, 2019 · Class II · Z-1812-2019: Lidstock states the incorrect expiration date for the product
- Apr 11, 2018 · Class II · Z-2015-2018: Product sterility may be compromised due to unsealed packaging.
- Oct 16, 2015 · Class II · Z-0207-2016: Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a signi

## Indications for use
The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter™ with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term 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. 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. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest X-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

Source page: https://510kreport.com/device/K132133
Methodology: https://510kreport.com/methodology