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510(k) Data Aggregation

    K Number
    K981386
    Device Name
    MANAN BLUNT NEEDLE
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-06-29

    (74 days)

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

    MANAN BLUNT NEEDLE

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

    For simplifying insertion of a guide-wire and/or catheter through various ports(such as a Touhy-Borst) used in intravascular administration sets.

    Device Description

    Blunt Needle

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a "Manan Blunt Needle." It's a regulatory document indicating substantial equivalence to a predicate device, and it does not contain information about acceptance criteria or a study proving device performance as requested.

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

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