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510(k) Data Aggregation

    K Number
    K013460
    Device Name
    SWIFT LOW PROFILE CUP (PRO CUP)
    Manufacturer
    SWIFT DELIVERY PRODUCTS
    Date Cleared
    2002-01-17

    (91 days)

    Product Code
    HDB
    Regulation Number
    884.4340
    Why did this record match?
    Applicant Name (Manufacturer) :

    SWIFT DELIVERY PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INDICATIONS FOR USE: - 1. Non-reassuring fetal status. - Failure of the fetus to deliver spontaneously following an appropriately 2. managed second stage. - Maternal need to avoid voluntary expulsive effort. 3. - 4. Inadequate maternal expulsive effort. - Selective shortening of the second stage when the fetal head is at the outlet 5. as defined by ACOG technical bulletin # 196 Aug. 1994.
    Device Description
    Not Found
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    K Number
    K973942
    Device Name
    SWIFT DELIVERY PRODUCT #300
    Manufacturer
    SWIFT DELIVERY PRODUCTS
    Date Cleared
    1997-12-12

    (77 days)

    Product Code
    HDB, 85H
    Regulation Number
    884.4340
    Why did this record match?
    Applicant Name (Manufacturer) :

    SWIFT DELIVERY PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Indications For Use for this vacuum device in childbirth are the following: Uterine inertia Maternal Exhaustion - ineffective voluntary effort Vertex Presentation Engagement of the Head Optional: A. Maternal distress B. Fetal distress
    Device Description
    The new product is an improved vacuum extractor cup. The improvement is found in the location of the vacuum tubing attachment point, vacuum release valve and an adaptor for electric vacuum pumps.
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    K Number
    K963287
    Device Name
    VACUUM CUP (004SD)
    Manufacturer
    SWIFT DELIVERY PRODUCTS
    Date Cleared
    1996-10-28

    (68 days)

    Product Code
    HDB
    Regulation Number
    884.4340
    Why did this record match?
    Applicant Name (Manufacturer) :

    SWIFT DELIVERY PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vacuum Extractor Cup used in child birth
    Device Description
    The new Tulip Cup is a design change to the current Mityvace (004M) vacuum extractor cup. The change is found in the location of the vacuum tubing attachment point.
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