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

    CATHETER, INTRAVASCULAR

    K Number: K881976 · Decision Aug 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    14
    Review Days
    85

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    Basic Information

    Device Name
    CATHETER, INTRAVASCULAR
    K Number
    K881976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Primrose Medical, Inc.
    Date Received
    May 11, 1988
    Decision Date
    August 4, 1988
    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 Primrose Medical, Inc.

    K Number Device Name
    K884714 BILIARY DIALATOR
    K884715 ACHELASIA BALLOON DIALATOR
    K884713 COLONIC BALLOON DIALATORS
    K884711 URETHRAL AND URETERAL BALLOON DILATATORS
    K884709 ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
    K884712 ESOPHAGEAL AND PYLORIC BALLOON DIALATORS
    K883420 LANCET, BLOOD
    K881977 PRESSURE INFUSOR
    K881975 SET, INTRAVASCULAR
    K881978 ENTERAL FEEDING TUBES
    Search all 14 clearances from Primrose Medical, Inc. →