BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM

    K Number: K851365 · Decision Dec 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    20
    Review Days
    242

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    Basic Information

    Device Name
    SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
    K Number
    K851365
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    April 5, 1985
    Decision Date
    December 3, 1985
    Product Code
    DXY
    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
    DXY Implantable Pacemaker Pulse-Generator

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    Other Clearances by Sorin Biomedica, Fiat, USA, Inc.

    K Number Device Name
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    K925369 BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
    K925615 SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE
    K924354 STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
    K925541 STOCKERT 1/4 BUBBLE SENSOR
    K922933 SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
    K854963 S80 IMPLANTABLE CARDIAC PACING LEAD
    K852641 ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
    K841947 ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT
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