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

    Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device

    K Number: K230429 · Decision Apr 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    108
    Applicant Total
    6
    Review Days
    59

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    Basic Information

    Device Name
    Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
    K Number
    K230429
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rapid Medical , Ltd.
    Date Received
    February 17, 2023
    Decision Date
    April 17, 2023
    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.

    K Number Device Name
    K253062 Tigertriever 25 Revascularization Device
    K251603 Tigertriever 17 Ultra Revascularization Device
    DEN230064 BraidE Embolization Assist Device
    K220808 Tigertriever 13 Revascularization Device
    K203592 Tigertriever and Tigertriever 17 Revascularization Devce