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510(k) Data Aggregation

    K Number
    K062577
    Device Name
    V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC
    Manufacturer
    TZ MEDICAL, INC.
    Date Cleared
    2006-12-15

    (106 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC

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

    The V1 Multi-port Connector is intended to be used primarily in electrophysiology (EP) laboratories as a multi-port connector with switching capabilities for connection to defibrillator, EP study equipment and electrosurgical devices. It provides a stable, focal location for multiple wires, cables and connections. The device allows the defibrillator to be used as a back-up for stimulating and pacing when those pieces of equipment are unavailable.

    Device Description

    The V1 Multi-port Connector is intended to be used primarily in electrophysiology (EP) laboratories as a multi-port connector with switching capabilities for connection to defibrillator, EP study equipment and electrosurgical devices. It provides a stable, focal location for multiple wires, cables and connections. The device allows the defibrillator to be used as a back-up for stimulating and pacing when those pieces of equipment are unavailable.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (VI Multiport Connector) and does not include details about acceptance criteria, study findings, sample sizes, expert qualifications, or ground truth establishment.

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