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

    HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT

    K Number: K882657 · Decision Dec 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    7
    Review Days
    167

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    Basic Information

    Device Name
    HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT
    K Number
    K882657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Harbor Medical Devices, Inc.
    Date Received
    June 29, 1988
    Decision Date
    December 13, 1988
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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    Other Clearances by Harbor Medical Devices, Inc.

    K Number Device Name
    K884628 HARBORIN CENTRAL VENOUS CATHETER
    K890518 SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM
    K881884 HARBOR CENTRAL VENOUS CATHETER
    K882190 S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM
    K880297 SEA - PORT INFUSION SET
    K874414 HYPODERMIC NEEDLES, SINGLE LUMEN