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

    NEUROEDGE INFUSION CATHETER

    K Number: K011646 · Decision Aug 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    174
    Applicant Total
    2
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NEUROEDGE INFUSION CATHETER
    K Number
    K011646
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuro Vasx, Inc.
    Date Received
    May 29, 2001
    Decision Date
    August 27, 2001
    Product Code
    KRA
    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
    KRA Catheter, Continuous Flush

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KRA), ordered by most recent decision date.

    Verge™ Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TruSelect™ 2.6 Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    InVera Infusion Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Micro Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Neuro Vasx, Inc.

    K Number Device Name
    K984258 NEUROVASX SUB-MICROINFUSION CATHETER