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510(k) Data Aggregation

    K Number
    K102592
    Device Name
    SUTRAZORB
    Manufacturer
    VISIONARY MEDICAL SUPPLIES, INC.
    Date Cleared
    2011-02-03

    (147 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONARY MEDICAL SUPPLIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sutrazorb Absorbable Surgical Sutures USP / EP are indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of Sutrazorb sutures in cardiovascular and neurological procedures have not been established.
    Device Description
    The Sutrazorb Absorbable PGA Suture (Sutrazorb Suture) is a sterile, surgical suture composed of monofilaments and braids of polyglycolic acid. The suture is dyed violet. The violet sutures are dyed with D&C Violet #2 in accordance with CFR Title 21 Part 74.3602, reference Section 6.0. The Visionary Medical Supplies' Sutrazorb Suture meets all requirements established by the United States Pharmacopoeia for absorbable surgical sutures. Testing to the following USP 32:2009 Monographs for Absorbable Sutures is discussed in Section 6.0: - Sutures - Diameter <861> - Sutures Needle Attachment <871> - Tensile Strength <881>
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    K Number
    K070243
    Device Name
    SUTRALENE POLYPROPYLENE SUTURES
    Manufacturer
    VISIONARY MEDICAL SUPPLIES, INC.
    Date Cleared
    2007-04-17

    (82 days)

    Product Code
    GAW
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONARY MEDICAL SUPPLIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sutralene polypropylene nonabsorbable sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
    Device Description
    This Sutralene Polypropylene Suture is a nonabsorbable, sterile, surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Those dyed blue are dyed with phthalocyaninato(2-) copper in accordance with Title 21 CFR Part 74.3045 and do not exceed 0.5% (w/w) suture. The sutures are uncoated.
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    K Number
    K994176
    Device Name
    SUTRALON NYLON SUTURES
    Manufacturer
    VISIONARY MEDICAL SUPPLIES, INC.
    Date Cleared
    2000-02-08

    (60 days)

    Product Code
    GAR
    Regulation Number
    878.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONARY MEDICAL SUPPLIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sutralon nonabsorbable synthetic polyamide suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    This non-absorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in a suitable construction for the intended size to meet current USP specifications. Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of suture. The braided suture may be uncoated or have a silicone coating, or a paraffin wax The mono nylon suture is uncoated. The suture thread has a needle coating. attached to it.
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    K Number
    K994177
    Device Name
    SUTRASILK SILK SUTURE
    Manufacturer
    VISIONARY MEDICAL SUPPLIES, INC.
    Date Cleared
    2000-02-08

    (60 days)

    Product Code
    GAP
    Regulation Number
    878.5030
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONARY MEDICAL SUPPLIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SutraSilk nonabsorbable silk sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    SutraSilk silk suture is a nonabsorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of suture. This non-absorbable suture is composed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specifications. The suture may be uncoated or have a silicone coating, a paraffin wax coating, or a natural gum coating (Virgin silk). The sutures come with needles attached.
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