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

    2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)

    K Number: K980723 · Decision Feb 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    14
    Review Days
    353

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    Basic Information

    Device Name
    2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)
    K Number
    K980723
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4885
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vascutech, Inc.
    Date Received
    February 24, 1998
    Decision Date
    February 12, 1999
    Product Code
    MGZ
    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
    MGZ Valvulotome

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    Other Clearances by Vascutech, Inc.

    K Number Device Name
    K001621 DARDIK CAROTID SHUNT
    K992942 LEMAITRE OCCLUSION CATHETER
    K992933 LEMAITRE IRRIGATION CATHETER
    K992934 LEMAITRE VENOUS THROMBECTOMY CATHETER
    K992940 LEMAITRE BALLOON CATHETER WITH IRRIGATION
    K992941 LEMAITRE BILIARY CATHETER
    K992368 LEMAITRE EMBOLECTOMY CATHETER
    K946352 LEMAITRE VALVULOTOME II
    K932009 THE SAMUELS RETROGRAD VALVULOTOME
    K932184 STERILE LEMAITRE GLOW 'N TELL TAPE
    Search all 14 clearances from Vascutech, Inc. →