# K122854: Arrow Glidethru Peel-Away Sheath/Dilator Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International (Subsidiary of Teleflex Inc.)
- Decided: Jan 4, 2013 after 108 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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: 1 generation back to K000313 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000313: Tearaway Introducer Sheath, Xentek Medical, Inc. (2000) Summary page 1.

## Recalls of this device
- Jun 12, 2017 · Class II · Z-2699-2017: Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may p
- 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 Arrow® GlideThruTM Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature. The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter TM with Chloragard® Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term 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 Arrow Pressure Injectable JACCTM may not exceed 300 psi. The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub. Chloragard 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 on catheter surfaces. Antimicrobial 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.

Source page: https://510kreport.com/device/K122854
Methodology: https://510kreport.com/methodology