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510(k) Data Aggregation

    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
    Cardiovascular
    Reference & Predicate Devices
    K162322,K052564,K171146
    Why did this record match?
    Reference Devices :

    K162322, K052564

    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.

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