# K161313: ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Decided: Aug 24, 2016 after 106 days
- Product code: PND (Midline Catheter)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 2 (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). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963257: Peripherally Inserted Medline Catheter, Arrow Intl., Inc. (1997) Summary page 4.
- K112896: Arrw Evolution, Arrow International (Subsidiary of Teleflex Inc.) (2012) Summary page 4.

## Most influential descendants
- K213855: Arrow Pressure Injectable Midline Catheter (2022), 0 descendants of its own

## Recalls of this device
- Sep 14, 2022 · Class II · Z-0102-2023: Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit
- Apr 23, 2019 · Class II · Z-1818-2019: Lidstock states the incorrect expiration date for the product

## Indications for use
The Arrow® Pressure Injectable Midline Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term (< 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Antimicrobial and Antithrombogenic Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4kPa). 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 and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic 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 or vein thrombosis.

Source page: https://510kreport.com/device/K161313
Methodology: https://510kreport.com/methodology