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

    MODEL PV2000 VASCULAR MICROLABORATORY

    K Number: K951486 · Decision Jun 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    6
    Review Days
    91

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    Basic Information

    Device Name
    MODEL PV2000 VASCULAR MICROLABORATORY
    K Number
    K951486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vasamedics, LLC
    Date Received
    March 30, 1995
    Decision Date
    June 29, 1995
    Product Code
    DPW
    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
    DPW Flowmeter, Blood, Cardiovascular

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    Other Clearances by Vasamedics, LLC

    K Number Device Name
    K962700 VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
    K961368 TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT
    K951832 LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433
    K912446 MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2
    K911763 LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)