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K Number
K181563
Device Name
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
Manufacturer
Access Scientific, LLC
Date Cleared
2018-09-26

(104 days)

Product Code
DQY,DYB
Regulation Number
870.1250
Type
Traditional
Panel
CV
Reference & Predicate Devices
K162322,K052564,K171146
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is an all-in-one preassembled device that combines the functionality of a catheter introducer system with an arterial catheter. The ARTERIAL WAND™ is used to gain access to the vascular (e.g. arterial) system to insert the arterial catheter. The arterial catheter may then be left in place for a period of

AI/ML Overview

I am sorry but this document does not contain the information required to answer your request. This document is related to a Medical Device Application for a catheter, and the questions are related to AI/ML device testing.

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).