# K121941: Arrow Picc Powered by Arrow VPS Stylet

- Pathway: 510(k) (Special)
- Applicant: Arrow International (Subsidiary of Teleflex Inc.)
- Decided: Sep 7, 2012 after 67 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: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 55 ancestors in all.
No later device cites it as a predicate yet.
3 of 56 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 3.
- K113277: Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter Kits, Arrow International, Inc. (2012) Summary page 1.
- K080604: Pressure Injfectable Picc, Arrow International, Inc. (2008) Summary page 3.

## Recalls of this device
- Aug 10, 2023 · Class II · Z-2591-2023: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Oct 17, 2017 · Class II · Z-0690-2018: The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.
- Jul 25, 2017 · Class II · Z-0601-2018: Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter
- Jun 1, 2017 · Class II · Z-0180-2018: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
- Jun 1, 2017 · Class II · Z-0181-2018: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
- 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
- Jul 30, 2015 · Class II · Z-2462-2015: the catheter peel-away component hub tabs may prematurely detach. One injury reported.
- 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.
- Jan 9, 2015 · Class III · Z-1030-2015: Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
- Mar 24, 2014 · Class II · Z-1494-2014: Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.

## Indications for use
The Pressure Injectable P1CC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of power injectors used with the pressure injectable P1CC catheter may not exceed 300 psi. The maximum pressure injection flow rate ranges from 4 mI/sec; to 6 mt/sec. Refer to the product specific labeling for the maximum pressure injection flow rate for the specific lumen being used for pressure injection. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffnuess 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/K121941
Methodology: https://510kreport.com/methodology