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

    CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085

    K Number: K992965 · Decision Nov 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    10
    Review Days
    85

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    Basic Information

    Device Name
    CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
    K Number
    K992965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cordis Webster, Inc.
    Date Received
    September 2, 1999
    Decision Date
    November 26, 1999
    Product Code
    DRF
    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
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

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    Other Clearances by Cordis Webster, Inc.

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    K982415 CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210
    K980961 CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.
    K970264 CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM
    K953663 CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
    K955817 CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER
    K954390 CORDIS WESTER STAR CATHETER
    K953768 CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER