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

    THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER

    K Number: K100819 · Decision Aug 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    8
    Review Days
    132

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    Basic Information

    Device Name
    THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
    K Number
    K100819
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Onset Medical Corporation
    Date Received
    March 23, 2010
    Decision Date
    August 2, 2010
    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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    K092014 SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
    K062852 BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
    K061009 PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
    K043254 PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH