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510(k) Data Aggregation

    K Number
    K123325
    Device Name
    Medafor Direct Gas-Assisted Application System
    Manufacturer
    MEDAFOR, INC.
    Date Cleared
    2013-01-24

    (90 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDAFOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to assist the delivery of a powdered hemostatic agent to the treatment site in surgical procedures including endoscopic surgeries, using a 5 mm or larger trocar.
    Device Description
    The MEDAFOR DIRECT Gas-Assisted Application System is intended to be used on patients undergoing surgery including laparoscopic procedures. The gas-assisted applicator kit and regulator are provided to assist the user in the application of powdered hemostatic agents to bleeding tissue in surgical procedures including laparoscopic/endoscopic surgeries, using a 5 mm or larger trocar. The device system consists of a Gas Regulator, Foot pedal, Tubing set, Adapter Handle, and FlexiTip XL-R rigid applicator. The gas regulator and foot pedal are supplied separately as non-sterile, reusable components. The Gas-Assisted Applicator kit is provided as a sterile, disposable unit, consisting of the tubing set, applicator adapter and a single unit of FlexiTip XL-R applicator.
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    K Number
    K033666
    Device Name
    HEMADERM
    Manufacturer
    MEDAFOR, INC.
    Date Cleared
    2003-12-17

    (26 days)

    Product Code
    QSY, LYA, NHB
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDAFOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological,) minor cuts, and lacerations and for the temporary treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
    Device Description
    HemaDerm™ containing MPH (Microporous Polysaccharide Hemospheres™ ) is manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells. The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal platelet activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.
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    K Number
    K021678
    Device Name
    HEMADERM COTAINING HEMADEX CLOTTING BEADS
    Manufacturer
    MEDAFOR, INC.
    Date Cleared
    2002-07-12

    (52 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDAFOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), minor cuts and lacerations. HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
    Device Description
    Medafor. Inc.'s HemaDerm™ consists of dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells. The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal platelet activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.
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    K Number
    K013225
    Device Name
    INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
    Manufacturer
    MEDAFOR, INC.
    Date Cleared
    2001-12-26

    (90 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDAFOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Over the Counter, OTC: Bleed-X™ is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations and abrasions. Prescription, Rx: Traumadex™ is intended as a topical dressing for the local management of bleeding wounds such as cuts, lacerations and abrasions. Under the care of a health care professional, Traumadex™ may be used for the temporary treatment of severely bleeding wounds such us surgical wounds (post-operative, donor sites, dermatological), cuts, lacerations and traumatic injuries.
    Device Description
    Medafor, Inc.'s Bleed-X™ and Traumadex™ consists of dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells. The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal plateler activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.
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