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

    BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter

    K Number: K231653 · Decision Jul 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    70
    Applicant Total
    6
    Review Days
    27

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    Basic Information

    Device Name
    BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
    K Number
    K231653
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thrombolex, Inc.
    Date Received
    June 6, 2023
    Decision Date
    July 3, 2023
    Product Code
    QEY
    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
    QEY Mechanical Thrombolysis Catheter

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    Other Clearances by Thrombolex, Inc.

    K Number Device Name
    K222095 BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
    K211061 BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)
    K193071 Bashir Plus Endovascular Catheter
    K192598 Bashir S-B Endovascular Catheter, Ref. No. 7101
    K183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200