Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252355

    Validate with FDA (Live)

    Date Cleared
    2025-11-26

    (120 days)

    Product Code
    Regulation Number
    880.5570
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K190233

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

    This device is an intravascular administration set with a non-coring Huber needle used for drug administration and blood sampling through implanted vascular port systems.

    The needle tip is equipped with an anti-needle stick protector to reduce the possibility of accidental needle sticks. This device is also applicable to high-pressure injection with power injectors, when used with a port system indicated for high-pressure injection.

    Device Description

    The K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (here in after K-SHIELD Advantage HP-PAIS) is an intravascular administration set with a non-coring Huber needle used for drug administration and blood sampling through implanted vascular port systems.

    The needle tip is equipped with an anti-needle stick protector to reduce the possibility of accidental needle sticks. This device is also applicable to high-pressure injection with power injectors, when used with a port system indicated for high-pressure injection.

    This device has a Huber needle for insertion into the septum of an implanted port, for infusion and blood sampling through the port. This needle is equipped with wings of a specific shape and rigidity to ensure that the user can securely hold the device during needle insertion and withdrawal. Additionally, the alignment of the gripping position and the puncture point along a straight line supports accurate puncture placement. The device features a safety mechanism that activates upon needle withdrawal, with a safety shield covering the needle tip.

    The activation of the safety mechanism is audibly confirmed by a click sound. Moreover, the device is equipped with high-pressure resistant tubing and clamp, enabling the supply of medications such as contrast media using an automatic injector.

    Specification

    Needle gaugeNeedle lengthTube length (mm)
    19G3/4"w/o Y site: 170
    With Y site: 100/100
    1"w/o Y site: 170
    With Y site: 100/100
    20G3/4"w/o Y site: 170
    With Y site: 100/100
    1"w/o Y site: 170
    With Y site: 100/100
    22G3/4"w/o Y site: 170
    With Y site: 100/100
    1"w/o Y site: 170
    With Y site: 100/100
    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1