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510(k) Data Aggregation

    K Number
    K112961
    Device Name
    CLO-SURPLUS P.A.D.
    Manufacturer
    SCION CARDIO-VASCULAR, INC.
    Date Cleared
    2011-10-31

    (27 days)

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

    SCION CARDIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scion Cardio-Vascular Clo-SurPUS P.A.D. is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, nose bleeds, surgical debridement sites, skin surface puncture sites, vascular sites, and sites involving percutaneous catheters, tubes and pins.
    Device Description
    The Scion Cardio-Vascular Clo-SurPLUS PADTM is a soft, nonwoven topical pad that provides an optimal wound healing environment, combining an effective antibacterial barrier activity with exudates management. An optional slit Clo-SurfLUS PAD™ allows for easier placement of the dressing around pins and tubes. Clo-Sur PLUS PADTM has demonstrated in-vitro antibacterial activity for up to 144 hours (6 days) in certain strains shown to be detrimental to wound healing such as: Escherichia Coli, Staphylococcus Aureus, Streptococcus pyogenes, Pseudomonas aeruginosa, Bacillus cereus, Enterococcus faecium, Candida Albicans and Asperigillus brasiliensis. Clo-SurPLUS PAD™ is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by E-beam radiation to a 10°6 SAL.
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    K Number
    K092552
    Device Name
    CLO-SURPLUS P.A.D.
    Manufacturer
    SCION CARDIO-VASCULAR, INC.
    Date Cleared
    2009-09-04

    (15 days)

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

    SCION CARDIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K052509
    Device Name
    M-BOLUS EMBOLIC MICROSPHERES
    Manufacturer
    SCION CARDIO-VASCULAR, INC.
    Date Cleared
    2006-12-11

    (454 days)

    Product Code
    HCG
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCION CARDIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The M-BolusTM Embolic Microspheres are intended for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors. They may be used for vascular occlusion of vessels within the neurovascular system when presurgical devascularization is desirable.
    Device Description
    M-BOLUSTM Embolic Microspheres are made out of a biocompatible, non-degradable and non-absorbable synthetic polymer called Polyvinyl Alcohol (PVA). The M-BOLUSTM Embolic Microspheres are precisely manufactured spheres, with a smooth and lightly porous surface with hydrophilic characteristics. The M-BOLUSTM Embolic Microspheres, which are supplied in a hydrated state (0.9% Sodium Chloride), are soft and flexible allowing them to be compressed/deformed as they travel through the lumen of a delivery catheter or the vasculature. The Scion Cardio-Vascular M-BOLUSTM Embolic Microspheres are substantially equivalent to the predicate devices.
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    K Number
    K032986
    Device Name
    CLO-SURPLUSP.A.D.
    Manufacturer
    SCION CARDIO-VASCULAR, INC.
    Date Cleared
    2004-03-01

    (159 days)

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

    SCION CARDIO-VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scion Cardio-Vascular Clo-SurPLUS P.A.D., is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose bleeds, and the skin surface puncture sites for vascular procedures, percutaneous catheters or tubes.
    Device Description
    The Scion Cardio-Vascular Clo-SurPLUS P.A.D. is a soft, non-woven pad that provides an optimal wound-healing environment, combining an effective antibacterial barrier activity with exudates management. Clo-SurPLUS P.A.D. has demonstrated in-vitro antibacterial activity meant to prevent microbial colonization and penetration of the dressing. Clo-SurPLUS P.A.D. is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by E-beam radiation to a 10-6 SAL.
    Ask a Question

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