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

    Aristotle 18 Guidewire; Aristotle 24 Guidewire

    K Number: K231954 · Decision Aug 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    39
    Applicant Total
    7
    Review Days
    29

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    Basic Information

    Device Name
    Aristotle 18 Guidewire; Aristotle 24 Guidewire
    K Number
    K231954
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scientia Vascular, Inc.
    Date Received
    July 3, 2023
    Decision Date
    August 1, 2023
    Product Code
    MOF
    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
    MOF Guide, Wire, Catheter, Neurovasculature

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    Other Clearances by Scientia Vascular, Inc.

    K Number Device Name
    K253579 Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire
    K243938 Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire
    K242301 Socrates 38 Catheter
    K223913 Socrates Aspiration System
    K223560 Plato 17 Microcatheter
    K222437 Aristotle Colossus Guidewire