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510(k) Data Aggregation

    K Number
    K961745
    Device Name
    BRAUN PERCUTANEOUS INTRODUCER SET
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Date Cleared
    1996-09-17

    (134 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K810460,K894446,K780126,K850820,K932733
    Why did this record match?
    Device Name :

    BRAUN PERCUTANEOUS INTRODUCER SET

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

    The Braun Percutaneous Introducer Kits are designed to facilitate percutaneous introduction of devices into the vasculature.

    Device Description

    Braun Percutaneous Introducer Kits consist of an introducer sheath packaged with a corresponding dilator. A guidewire and introducer needle may also be packaged with the sheath and dilator.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device (Braun Percutaneous Introducer Set) and primarily focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports for AI/ML devices.

    Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a traditional medical device, not an AI/ML powered device, and thus does not contain the specific study design elements you've asked for.

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