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510(k) Data Aggregation

    K Number
    K151204
    Device Name
    HEMO-Bandage
    Manufacturer
    CORELEADER BIOTECH CO., LTD.
    Date Cleared
    2015-07-31

    (87 days)

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

    CORELEADER BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.
    Device Description
    CoreLeader HEMO-Bandage is woven gauze made of chitosan fiber and rayon fiber. Chitosan is a type of organic polysaccharide carrying positively-charged ions. Appearing light yellow color and inheriting biodegradability and biocompatibility of chitosan. CoreLeader HEMO-Bandage achieves hemostasis by attracting erythrocytes to the injured sites and facilitates blood clot formation. CoreLeader HEMO-Bandage is sterilized by gamma-ray radiation to 10th SAL after packed in a foil bag. With the softness and flexibility, it is readily conformable to various wound shapes.
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    K Number
    K141382
    Device Name
    BIOS KING BIOCELLULOSE FILM
    Manufacturer
    CORELEADER BIOTECH CO., LTD.
    Date Cleared
    2015-02-10

    (259 days)

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

    CORELEADER BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bios King Biocellulose Film is indicated as a topical dressing to manage pressure sores, diabetic ulcers, 1st to 2nd degree burns and skin donor sites.
    Device Description
    Bios King Biocellulose Film is made of bacterial synthesized cellulose mesh with a selectively permeable structure allowing water evaporation, and thus provides a moist but not damp environment for wound healing. Bios King Biocellulose Film is resistible to the tensile force generated from the wound handing. It can adhere to wound beds without fixation devices.
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    K Number
    K123394
    Device Name
    CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
    Manufacturer
    CORELEADER BIOTECH CO., LTD.
    Date Cleared
    2013-06-06

    (216 days)

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

    CORELEADER BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coreleader Hydro-clear is indicted for the management of 1st and 2nd degree burns, chronic ulcers, surgical wounds, skin graft and donor sites. Patient with conditions listed below is considered appropriate for Over-The Counter Use (OTC): for the management of minor cuts, minor burns (1st degree burns), minor lacerations and minor cuts.
    Device Description
    Coreleader Hydro-clear is a new product that is made of Hydrocolloid (Sodium carboxymethyl cellulose, Synthetic Elastomer, Tackifier Resins, Mineral Oil and Polyurethane film) by unique production process. With preferable liquid absorbsion ability, gas permeability and ability of water resistant, Hydro-clear is clear of adhesive onto wound, capable to absorb exudates, protect wound site and facilitates would healing process.
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    K Number
    K111578
    Device Name
    CORELEADER COLLA-ALGI FIBER MODEL CAW
    Manufacturer
    CORELEADER BIOTECH CO., LTD.
    Date Cleared
    2011-09-23

    (108 days)

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

    CORELEADER BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coreleader Colla-Algi Fiber Dressing is indicated for management of exuding wounds including: - Full-thickness and partial-thickness wounds . - Pressure ulcers . - Venous ulcers - Ulcers caused by mixed vascular etiologies . - Diabetic ulcers ● - Second-degree burns ● - Donor sites and other bleeding surface wounds ● - Abrasions - Traumatic wounds healing by secondary intention . - Dehisced surgical incisions .
    Device Description
    Coreleader Colla-Alig Fiber Dressing with Alginate is wound care dressing with 10% collagen composition. Colla-Alig Fiber Wound Dressing with Alginate combines with exudate to maintain a moist wound environment. The moist environment provided by the Colla-algi fibers may provide an environment favorable to the wound healing process. It is non-adherent, removes easily and leaves wound free of fiber. It maintains initial integrity when wet. Soft, conformable sheet can be cut to fit any size wound. Coreleader Colla-Algi Fiber Dressing with Alginate is an advanced wound care device composed of collagen and calcium alginate fibers. Its unique combination of natural biopolymers created by Wet-Spinning process combines the structure support of collagen and gel forming properties of alginates into a sterile, soft, absorbent. conformable topical wound dressing. The dressing is manufactured from bovine collage and medical grade alginate.
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    K Number
    K111733
    Device Name
    CORELEADER SCAR-DIMMER
    Manufacturer
    CORELEADER BIOTECH CO., LTD.
    Date Cleared
    2011-09-22

    (93 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORELEADER BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coreleader Scar-D Silicone Sheeting is intended for use: for the management of closed hypertrophic and keloid scars.
    Device Description
    Coreleader Scar-D silicone sheeting is a thin, soft and self-adhesive sheet made from medical grade silicone with a PU Foam/PU non-woven film backing paper and a non-silicone polyester release paper. It is able to hold moisture with adequate pressure on the scar. The sheets are rectangular and come in four sizes, 5 cm x 8 cm, 5 cm x 20 cm, 2.5 cm x 100 cm and 5 cm x 100 cm. They are approximately 0.6 mm thick. The sheet maybe cut or trimmed to the desired shape or size prior to placement on the scar. The sheets are not for use on an open wound, are not sterile but can be washed.
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    K Number
    K102944
    Device Name
    CORELEADER HEMO-PAD MODEL CPII 02030
    Manufacturer
    CORELEADER BIOTECH CO., LTD.
    Date Cleared
    2011-09-07

    (338 days)

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

    CORELEADER BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coreleader Hemo-Pad is a dressing indicated for topical wound management and for the external topical temporary control of moderate to severe bleeding. The dressing is indicated for the following wounds: abrasions, lacerations, skin surface puncture sites for vascular procedures (arteries and veins)
    Device Description
    The Coreleader Hemo-Fiber wound dressing is made from poly-D-glucosamine and poly-N-acetylglucosamine derived from chitosan. The Coreleader Hemo-Fiber is a soft, non-woven topical pad for hemostasis and wound care. The natural biological property of this material carries cation (positively charged ion) that helps to stop external hemorrhage, and the Coreleader Hemo-Fiber wound dressing absorbs the wound exudates to form a hydrogel while providing protection layer layer for an optimal wound-healing environment. Coreleader Hemo-Pad is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by gamma-ray radiation to a 10to SAL.
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    K Number
    K102942
    Device Name
    CORELEADER ALGIPLASTER MODEL AP 050501
    Manufacturer
    CORELEADER BIOTECH CO., LTD.
    Date Cleared
    2011-06-22

    (261 days)

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

    CORELEADER BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The following conditions are considered appropriate for OTC use by the lay person: Coreleader AlgiPlaster is indicated for the management minor abrasions, minor cuts and minor lacerations. The following conditions are considered appropriate for Prescription Use under the supervision of a licensed healthcare provider: Coreleader AlgiPlaster is indicated as a primary dressing for the management of exuding wounds, including acute wounds such as abrasions, lacerations and post-surgical wounds.
    Device Description
    Coreleader AlgiPlaster is composed of Alginate fiber and combined with the thin polyurethane membrane coated with a layer of an acrylic adhesive. The dressing combination, which is permeable to both water vapor and oxygen, is impermeable to micro-organisms and once in position, it provides an effective barrier to external contamination, and producing a moist environment at the surface of the wound by reducing water vapor loss from the exposed tissue. The moist environment provided by the alginate fibers may provide an environment favorable to the wound healing process. Coreleader AlgiPlaster is a sterile topical wound dressing, packed in individual pouch and sterilized by r-ray radiation to a 106 SAL.
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    K Number
    K102946
    Device Name
    CORELEADER COLLA-PAD MODEL CS 03030
    Manufacturer
    CORELEADER BIOTECH CO., LTD.
    Date Cleared
    2011-05-20

    (228 days)

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

    CORELEADER BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coreleader Colla-Pad Wound Dressing is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/ undermined wounds, surgical wounds, (donor sites/grafts, post-Mohs surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.
    Device Description
    Coreleader Colla-Pad is comprised of a porous matrix of cross-linked bovine collagen. Colla-Pad is made of highly absorbent material that converts to a soft, gel sheet that stays in intimate contact with the wound bed as it absorbs exudate t. The moisture held around the wound by Colla-Pad could provide a favorable wound healing environment. Coreleader Colla-Pad is easy to cut and apply. Cut to fit any size of acute or chronic wounds with light to heavy exudate. Coreleader Colla-Pad is a sterile topical wound dressing, packed in a foil pouch and a foil package and sterilized by r-ray radiation to a 10to SAL.
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    K Number
    K102943
    Device Name
    CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050
    Manufacturer
    CORELEADER BIOTECH CO., LTD.
    Date Cleared
    2011-04-12

    (190 days)

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

    CORELEADER BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The following indications for use of the product should be managed under the supervision of a health care professional: Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of moderate to heavily exuding wounds, partial and full thickness wounds including chronic wounds such as leg ulcers, pressure sores and acute wounds such as donor sites, abrasions, lacerations and post-surgical wounds. The following conditions are considered appropriate for OTC use by the lay person: - · Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of minor exuding wounds such as minor abrasions, minor lacerations and minor post-surgical wounds.
    Device Description
    Coreleader Algi-Fiber wound dressing is composed of calcium alginate fiber. It is softness and therefore Coreleader Algi-Fiber wound dressing is suitable for wound surface regardless the location, size, sinus and depth of a patient. Due to its highly hydrophilic property, the Coreleader Algi-Fiber wound dressing absorbs the wound exudates to form a hydrogel protection layer. The Coreleader Algi-Fiber wound dressing is biocompatibility. It has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant. Coreleader Algi-Fiber is a sterile topical wound dressing, packed in individual pouch and sterilized by r-ray radiation to a 10° SAL.
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