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

    INFUSION MANIFOLD

    K Number: K873852 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    64
    Review Days
    62

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    Basic Information

    Device Name
    INFUSION MANIFOLD
    K Number
    K873852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Advanced Surgical Products, Inc.
    Date Received
    September 22, 1987
    Decision Date
    November 23, 1987
    Product Code
    FPK
    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
    FPK Tubing, Fluid Delivery

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    Other Clearances by Advanced Surgical Products, Inc.

    K Number Device Name
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    K896754 I/A HANDPIECE
    K896305 MULTI-USE I/A HANDPIECE
    K884557 ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
    K884556 DREYER CURVED ENDOILLUMINATOR
    K890398 RYAN-STYLE DIRECTED INFUSION MANIPULATOR
    K884347 MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
    K883857 FIBEROPTIC WIRE PICK LIGHTPIPE
    K883858 FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE
    Search all 64 clearances from Advanced Surgical Products, Inc. →