BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Tigertriever and Tigertriever 17 Revascularization Devce

    K Number: K203592 · Decision Mar 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    96
    Applicant Total
    4
    Review Days
    105

    Basic Information

    Device Name
    Tigertriever and Tigertriever 17 Revascularization Devce
    K Number
    K203592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rapid Medical Ltd.
    Date Received
    December 8, 2020
    Decision Date
    March 23, 2021
    Product Code
    NRY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NRY Catheter, Thrombus Retriever

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    Other Clearances by Rapid Medical Ltd.

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