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

    PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING

    K Number: K002707 · Decision Nov 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    7
    Review Days
    70

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    Basic Information

    Device Name
    PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING
    K Number
    K002707
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Vascular Systems, Inc.
    Date Received
    August 30, 2000
    Decision Date
    November 8, 2000
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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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
    K020733 PVS 1500 SDS
    K002907 PVS 1300 NEURO GUIDE WIRE
    K990823 PVS 1400 GUIDEWIRE