# K141618: Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet Plus

- Pathway: 510(k) (Special)
- Applicant: Arrow International, Inc (Subsidiary of Teleflex I
- Decided: Jul 8, 2014 after 21 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K001901 (2000). 60 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 62 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.
- K122545: CG+ Arrow Picc Powered by Arrow VPS Stylet, Arrow International (Subsidiary of Teleflex Inc.) (2012) Summary page 1.
- K123759: CG+ Arrow Picc Powered by Arrow VPS Stylet, Arrow International, Inc. (Subsidiary of Teleflex (2013) Summary page 4.
- K130876: CG+ Arrow Picc Powered by Arrow VPS Stylet, Arrow International, Inc. (2013) Summary page 1.

## Most influential descendants
- K153487: CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS (2016), 0 descendants of its own

## Indications for use
The VI'S Stylet and Console an indicated ror guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement or the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VI'S 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 VI'S 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, stadard 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 atriall fibrillation, trial 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 I'-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. The Pressur Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral 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 ofpressure injection equipment used with the pressure injectable P1CC catheter may not exceed 300 psi. 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 effecive in reducing microbial colonization and thronmbus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these test methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis. 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 ECO detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-ime catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VI'S System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The VI'S System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venious catheter tip placement confinnation in adult patients when asteady Blue Bullseye is obtained. NOTE: If asteady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contrindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atria] 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 theP-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/K141618
Methodology: https://510kreport.com/methodology