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

    CVD BULLETT PERIPHERAL INFUSION CATHETER

    K Number: K943023 · Decision Sep 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    11
    Review Days
    98

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    Basic Information

    Device Name
    CVD BULLETT PERIPHERAL INFUSION CATHETER
    K Number
    K943023
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiovascular Dynamics, Inc.
    Date Received
    June 24, 1994
    Decision Date
    September 30, 1994
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Cardiovascular Dynamics, Inc.

    K Number Device Name
    K973713 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR
    K971577 FOCUS-PV BALLOON DILATATION CATHETER
    K963989 P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
    K963688 FOCUS PV BALLOON DILATATION CATHETER
    K945693 CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER
    K952064 FOCUS BALLOON DILATATION CATHETER
    K951502 CVD BULLET INFUSION CATYHETER
    K951503 CVD BULLETT HI-FLO INFUSION CATHETER
    K944016 FOCUS BALLOON DILATATION CATHETER
    K945465 CVD SMALL VESSEL BALLOON DILATATION CATHETER
    Search all 11 clearances from Cardiovascular Dynamics, Inc. →