LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K011790
    Device Name
    MICROCRUISER PLUS INTRODUCER SET
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    2001-09-05

    (89 days)

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

    MICROCRUISER PLUS INTRODUCER SET

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

    The MicroCruiser® Plus Introducer Set is intended for use in the introduction and placement of guidewires and/or catheters.

    Device Description

    The MicroCruiser® Plus Introducer Set is comprised of an .018" diameter guidewire, a guidewire introducer needle, and a coaxial introducer that has a diameter suitable for catheter introduction and placement. The introducer tubing is made from biocompatible polyurethane that has been used extensively in both short and long term catheters. The introducers are provided in the following French sizes: 3 (Inner)/4 (Outer), 3 (Inner)/5 (Outer), and 4 (Inner)/6 (Outer), and in lengths of 10 cm.

    AI/ML Overview

    This document is a 510(k) summary for the MicroCruiser® Plus Introducer Set. It outlines the device description, indications for use, and a comparison to a predicate device for substantial equivalence. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

    Therefore, I cannot provide the requested information based on this document. The provided text is a regulatory submission for device clearance, not a study report detailing performance metrics and validation.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1