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

    PVS 1500 SDS

    K Number: K020733 · Decision Mar 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    174
    Applicant Total
    7
    Review Days
    15

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    Basic Information

    Device Name
    PVS 1500 SDS
    K Number
    K020733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Vascular Systems, Inc.
    Date Received
    March 6, 2002
    Decision Date
    March 21, 2002
    Product Code
    KRA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    KRA Catheter, Continuous Flush

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    Other Clearances by Precision Vascular Systems, Inc.

    K Number Device Name
    K032494 PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER
    K032146 PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
    K023700 PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE
    K002907 PVS 1300 NEURO GUIDE WIRE
    K002707 PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING
    K990823 PVS 1400 GUIDEWIRE