# K160018: Arrow Quickflash Arterial Catheterization Device

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Decided: Jun 13, 2016 after 160 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K810675 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
2 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810675: Arrow Radial Artery Catheterization Set, Arrow Intl., Inc. (1981) Summary page 4.

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2397-2026: 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
- Feb 12, 2024 · Class I · Z-1267-2024: Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the 

## Indications for use
The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.

Source page: https://510kreport.com/device/K160018
Methodology: https://510kreport.com/methodology