# K181563: The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

- Pathway: 510(k) (Traditional)
- Applicant: Access Scientific, LLC
- Decided: Sep 26, 2018 after 104 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K810675 (1981). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171146: Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga., Arrow International, Inc. (Subsidiary of Telelflex Inc.) (2017) Summary page 5.

## Indications for use
The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is used to gain access to the vascular (e.g. arterial) system to sample blood, administer fluids, and monitor blood pressure intravascularly.

Source page: https://510kreport.com/device/K181563
Methodology: https://510kreport.com/methodology