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510(k) Data Aggregation

    K Number
    K960055
    Device Name
    MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932
    Manufacturer
    PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
    Date Cleared
    1996-09-30

    (270 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found. This document is a certification and summary for a 510(k) submission, but it does not contain the detailed information requested regarding a medical device for imaging or AI/ML.

    Device Description

    Not Found

    AI/ML Overview

    Analysis of Provided Information to Answer the Request

    The input provided is a "PREMARKET APPROVAL NOTIFICATION CERTIFICATION AND SUMMARY" for the BioGlide Vascular Catheter, single lumen. This document does not contain any information about acceptance criteria or a study proving the device meets said criteria.

    Instead, it lists potential complications associated with the use of the device and certifies that the submitter is aware of these problems. It is a general statement about potential risks, not a performance study.

    Therefore, I cannot provide the requested information based on the input.

    To answer your request, I would need a document describing:

    1. Specific performance metrics and their corresponding acceptance criteria. (e.g., "Tensile strength must be > X Newtons," "Flow rate must be > Y ml/min," "Insertion force must be
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