# K113277: Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter Kits

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc.
- Decided: Jun 21, 2012 after 227 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: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 25 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061289: Arrow Pressure Injectable Picc, Arrow International, Inc. (2006)
- K073451: Pressure Injectable Picc, Arrow International, Inc. (2008) Summary page 1.
- K080604: Pressure Injfectable Picc, Arrow International, Inc. (2008) Summary page 1.

## Most influential descendants
- K140129: Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry Catheter (2014), 0 descendants of its own
- K121941: Arrow Picc Powered by Arrow VPS Stylet (2012), 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
- Dec 20, 2019 · Class II · Z-1254-2020: Product lidstock contains the incorrect expiration date for the product
- Apr 11, 2018 · Class II · Z-2023-2018: Product sterility may be compromised due to unsealed packaging.
- Jul 25, 2017 · Class II · Z-0602-2018: 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-0182-2018: 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

## Indications for use
The ArrowADVANTAGETM Pressure Injectable PICC 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 of pressure injector equipment used with the ArrowADVANTAGETM Pressure Injectable PICC may not exceed 300 psi.

Source page: https://510kreport.com/device/K113277
Methodology: https://510kreport.com/methodology