LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980994
    Device Name
    IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES
    Manufacturer
    VENETEC INTL., INC.
    Date Cleared
    1998-05-29

    (73 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES

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

    An intravascular administration set with needle access to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vessel.

    Device Description

    IV Extension/Administration Sets with Needle

    AI/ML Overview

    The provided text pertains to a 510(k) premarket notification for an "IV Extension/Administration Sets with Needle" device (K980994) received by the FDA in 1998. The document is an FDA clearance letter confirming substantial equivalence to a predicate device.

    This document does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone performance), or training set information for an AI/algorithm-based device.

    The document is a regulatory clearance letter for a physical medical device (IV administration sets), not a software or AI medical device. Therefore, the questions posed in the prompt about AI/algorithm performance and study methodologies are not applicable to the content provided.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1