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

    OLYMPUS ANGIOSCOPY PUMP

    K Number: K871422 · Decision Aug 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    142
    Review Days
    125

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    Basic Information

    Device Name
    OLYMPUS ANGIOSCOPY PUMP
    K Number
    K871422
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Olympus Corp.
    Date Received
    April 9, 1987
    Decision Date
    August 12, 1987
    Product Code
    DQI
    Advisory Committee
    Cardiovascular
    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
    DQI Withdrawal/Infusion Pump

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    Other Clearances by Olympus Corp.

    K Number Device Name
    K915402 EW-10 AND EW-20
    K933200 OLYMPUS PBD STENTS
    K942338 OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES
    K931763 HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
    K934835 FLOVAL
    K931764 HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES
    K915857 FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE
    K931994 RESECTOSCOPE SHEATH
    K933992 OLYMPUS SCLEROTHERAPY BALLOON
    K934361 OLYMPUS CREATININE REAGENT
    Search all 142 clearances from Olympus Corp. →