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

    CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM

    K Number: K970264 · Decision Oct 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    10
    Review Days
    278

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    Basic Information

    Device Name
    CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM
    K Number
    K970264
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cordis Webster, Inc.
    Date Received
    January 23, 1997
    Decision Date
    October 28, 1997
    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 Cordis Webster, Inc.

    K Number Device Name
    K992965 CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
    K991531 CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
    K982740 CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S
    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.
    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