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510(k) Data Aggregation

    K Number
    K180994
    Device Name
    SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
    Manufacturer
    Interrad Medical Inc
    Date Cleared
    2019-07-09

    (449 days)

    Product Code
    KMK, OKC
    Regulation Number
    880.5210
    Why did this record match?
    Product Code :

    KMK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SecurAcath device is indicated for catheter securement to the access site by means of subcutaneous anchors in: a) Short or long-term securement of percutaneous indwelling catheters for intravenous use b) Short or long-term securement of percutaneous indwelling catheters for abscess/general drainage
    Device Description
    The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.
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    K Number
    K981860
    Device Name
    A P HARNESS
    Manufacturer
    PARAWORKS ENTERPRISE, LTD.
    Date Cleared
    1999-06-03

    (372 days)

    Product Code
    KMK
    Regulation Number
    880.5210
    Why did this record match?
    Product Code :

    KMK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AP Harness is to be used as a safety line between a patient and a medical machine which are connected by a medical line, (ie IV tubing, oxygen tubing, enteral tubing, etc. ). This device would be used when the patient or caregiver cannot maintain an adequate level of safety for an important catheter or other medical line.
    Device Description
    The A.P. Harness System facilitates increased safety and comfort of the active child or other patient while he/she is hooked-up to TPN, IV, enteral tube feed or other medical lines. This safety is accomplished by providing the maximum distance between the child and pump stand, determined by the length in the medical lines. This allows the child better access to his/her environment. The harness also limits kinking and subsequent occlusion in the medical lines. This frees the child from interruptions in play, while the caregiver searches for the location of an occlusion in the medical lines. Another benefit is increased safety and lowered stress for the caregiver. This means the supervision of the medical lines is done less intensively, and therefore the caregiver's attention can be directed to the child as a whole person and not just as a patient. This system is comprised of a harness, a tether strap, an anchor strap, and a zipper sleeve. It is equipped with buckles that are small, low profile, strong, and secure. The shoulder straps are moveable along the chest strap; this facilitates infinite adjustability for a growing patient or for multiple patient use. The chest strap is worn directly underneath the axillas (armpits), which facilitates unhindered diaper changes and avoids soiling. The harness's location high on the chest puts the minimum amount of restriction on the respiratory system, as well as keeping access for common medical evaluations and nursing procedures. The chest strap is made of soft tubular webbing, which contours to the patients chest, preventing abrasion and pinching.
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    K Number
    K963365
    Device Name
    MULTI-PURPOSE MEDICAL TUBE HOLDER
    Manufacturer
    BYRD MEDICAL DEVICES, INC.
    Date Cleared
    1996-10-11

    (45 days)

    Product Code
    KMK
    Regulation Number
    880.5210
    Why did this record match?
    Product Code :

    KMK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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