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510(k) Data Aggregation

    K Number
    K030715
    Device Name
    SAFFRON NM GUIDING CATHETER
    Manufacturer
    NEICH MEDICAL (SHENZHEN) COMPANY LIMITED
    Date Cleared
    2003-04-24

    (48 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SAFFRON NM GUIDING CATHETER

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

    The Saffron NM™ Guiding Catheter is indicated for use for intravascular introduction of interventional/diagnostic devices into coronary or peripheral vascular systems.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Saffron NM™ Guiding Catheter." It is not a study demonstrating the device meets acceptance criteria.

    The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving individual performance metrics in the same way a clinical trial for a new drug or a novel AI algorithm would.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not present in this document. This letter simply states that the FDA has determined the device is "substantially equivalent" to predicate devices for its stated indications for use.

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