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510(k) Data Aggregation

    K Number
    K022868
    Device Name
    PRIMAGARD SURGICAL EQUIPMENT DRAPES
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-11-08

    (71 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMELINE MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The primaGARD Surgical Equipment Covers are Non-sterile surgical equipment covers, identified in 21 CFR, part 878.4370. The drapes are made of natural and/or synthetic material and used as a protective equipment covering. The primary purpose of this drape is to isolate equipment from contaminating the sterile field during surgery. This is to maintain the sterile technique in an operating room.
    Device Description
    The primaGARD Surgical Equipment Covers are Non-sterile surgical equipment covers, identified in 21 CFR, part 878.4370. The drapes are made of natural and/or synthetic material and used as a protective equipment covering.
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    K Number
    K023117
    Device Name
    PRIMAGARD SURGICAL GOWNS
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-11-08

    (58 days)

    Product Code
    KKX, FYA
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMELINE MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The primaGARD Surgical Drapes are Non-sterile Surgical Gowns, identified in 21 CFR, part 878.400, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    primaGARD Surgical Gowns
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    K Number
    K023266
    Device Name
    PRIMAGARD SURGICAL GOWNS
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-11-08

    (39 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMELINE MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The primaGARD Surgical Drapes are Non-sterile Surgical Gowns, identified in 21 CFR, part 878.4970, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    primaGARD Surgical Gowns
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    K Number
    K021864
    Device Name
    PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-09-23

    (109 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMELINE MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The primaGARD Surgical Drapes are NoNSterile Surgical Drape, identified in 21 CFR, part 878.4730, as a medical device intended to be used by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The drapes are made of natural and/or synthetic material and used as a protective patient covering. One example of use of this drape is to isolate the site of surgical incision from particulate, microbial and other forms of contamination.
    Device Description
    The primaGARD Surgical Drapes are NoNSterile Surgical Drape, identified in 21 CFR, part 878.4730, as a medical device intended to be used by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The drapes are made of natural and/or synthetic material and used as a protective patient covering.
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    K Number
    K021076
    Device Name
    PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-04-16

    (13 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMELINE MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    Not Found
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    K Number
    K011789
    Device Name
    PROCEDURE MASKS: PM4-301 AND PM4-304
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    2001-06-22

    (14 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMELINE MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intended to be world by operating room personnel from the transfer of protect bour the barger fluids, and particulate matcrial.
    Device Description
    Procedure Masks PM 4-301 + Pm4-31
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    K Number
    K001951
    Device Name
    PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    2000-09-08

    (73 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMELINE MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K971076
    Device Name
    PRIMED SHOE COVERS, PRIMED HEAD COVERS
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-01-13

    (295 days)

    Product Code
    FXP
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMELINE MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Apparels, shoe and head covers, are worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    PrimeLine Medical Products Inc., priMED brand Head and Shoe Covers
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    K Number
    K971075
    Device Name
    PRIMED PRIME-PLUS COTTON GAUZE SPONGES
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-06-22

    (90 days)

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

    PRIMELINE MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cotton Gauze Sponges are designed as single use, and general use medical devices in the management of wounds.
    Device Description
    Cotton Gauze Sponges
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