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510(k) Data Aggregation

    K Number
    K954906
    Device Name
    FIRST PICC INTRODUCER CATHETER
    Manufacturer
    BECTON DICKINSON VASCULAR ACCESS, INC.
    Date Cleared
    1996-04-08

    (166 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FIRST PICC INTRODUCER CATHETER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use is to facilitate the placement of other devices such as guidewires, central venous catheters, peripherally inserted central venous catheters, and probes in the vascular system.

    Device Description

    The subject catheter is a short term, single use introducer catheter of various gauges and lengths which is designed to split and peel away following use. It is inserted into the vascular system over a needle.

    AI/ML Overview

    This document (K954906) is a 510(k) premarket notification for an introducer catheter. It outlines the device description, intended use, and comparison to predicate devices for demonstrating substantial equivalence. It does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert involvement, or AI-related aspects.

    Therefore, I cannot provide the requested information as it is not present in the provided text.

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