BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SPECTRA GUIDEWIRE INTRODUCER NEEDLE

    K Number: K082580 · Decision Dec 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    6
    Review Days
    94

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    Basic Information

    Device Name
    SPECTRA GUIDEWIRE INTRODUCER NEEDLE
    K Number
    K082580
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectra Medical Devices, Inc.
    Date Received
    September 5, 2008
    Decision Date
    December 8, 2008
    Product Code
    DYB
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DYB Introducer, Catheter

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    Other Clearances by Spectra Medical Devices, Inc.

    K Number Device Name
    K151069 SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
    K103740 SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
    K082689 STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
    K082674 SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
    K081524 SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L