# K130876: CG+ Arrow Picc Powered by Arrow VPS Stylet

- Pathway: 510(k) (Special)
- Applicant: Arrow International, Inc.
- Decided: Apr 26, 2013 after 28 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: 4 (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). 58 ancestors in all.
2 later devices descend from it; 1 cites it directly.
5 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123759: CG+ Arrow Picc Powered by Arrow VPS Stylet, Arrow International, Inc. (Subsidiary of Teleflex (2013) Summary page 1.

## Most influential descendants
- K141618: Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet Plus (2014), 1 descendant of its own
- K153487: CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS (2016), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2378-2026: 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-1809-2019: Lidstock states the incorrect expiration date for the product
- Apr 11, 2018 · Class II · Z-2025-2018: Product sterility may be compromised due to unsealed packaging.
- Jul 30, 2015 · Class II · Z-2489-2015: saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.

## Indications for use
The Pressure Injectable P1CC with Chloag4-ard Antimicrobial and Antithrombogenic Technology is indicated for shoam-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling. infusion, pressure injection OfContras media and allows for central venous pressure, monitoring;The maximum Pressure of pressuire injection equipment used with the pressure injectable PICC cathecter mnay not exced 30Oiti.- Chionrard Technology trmentC On the extl surface! Of the catheter body as well as the entire fluid pathway of thtecatheter has been shtown to be effecive in reducing microbial colonization and thrombus accumulation on catheter sturfaces. Antimicrobial and antithroibogiciic effectiveness were evaluated using in tiroand in v/io test methods and no correlation between these lest methods and clinical outcome has currently been ascented. It is not intended to be used for the treatment of existing; infections or vein thrombosis. The VI'S Stylet and Console arc indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the cathetear, intravascular capability for ECG detection and recording and intraviactlar ultrasound for catheter guiding and positioning. The VPS Stylet, whten used wvith the VI'S Console, provides real-timei 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 inthe desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venious cathete tip placement confirmtation in adult patients when a steady" Blue Bullseye isobtained. NOTE: If a steady Blue Bullseye is not obtained. standard hospital practice should be followed to conifirm catheter tip location. Limiting hut not cointraindicated situations for this technique are in patients where alterations of cardiac rttythm change the presentation of the P-wave asin atrial fibrillation. atrial fautter. severe tachycardia and pacennaker-driven rhythm. and in central venous catheteration procedures performed through femnoral 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 toconifirm catheter tip location.

Source page: https://510kreport.com/device/K130876
Methodology: https://510kreport.com/methodology