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510(k) Data Aggregation

    K Number
    K964439
    Device Name
    NEEDLE-FREE VALVED CONNECTOR AND CAP
    Manufacturer
    BMW MEDICAL, INC.
    Date Cleared
    1997-07-16

    (252 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMW MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BMW Needlefree Valved Connector is designed for needlefree access to IV infusion systems for injection of fluids or aspiration of blood samples.
    Device Description
    BMW's Needlefree Valved Connector is a rigid plastic adapter with a male luer port on the distal end for attachment to I.V. access systems (e.g., catheters). The proximal end terminates in a female luer lock fitting which may be attached to any I.V. administration set terminating in a standard male luer. The female luer is capped when napt in use to minimize the potential for contamination. The plastic adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve is normally closed when it is not in use. The valve opens towards the I.V. access system when fluids are infused into the patient and it opens away from the I.V. access system to permit aspiration of blood samples. The valve is captured (sandwiched) between the seating surfaces of the two-piece adapter. The seating surfaces of the adapter are held in position by a bond between the proximal and distal pieces of the adapter. The connector valve is packaged in a sterile blister pack with male luer cap(s). The caps will also be packaged and sold individually.
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    K Number
    K963806
    Device Name
    CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)
    Manufacturer
    BMW MEDICAL, INC.
    Date Cleared
    1996-12-12

    (80 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMW MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BMW's multi-lumen central venous catheters have the same intended use as Bard Access Systems' Groshong long-term central venous catheters, and Bard's Hickman preamendment long-term central venous catheters. BMW's Clampless Valved Catheter-Tunneled is designed for patients who require long-term access to the central venous system for administration of fluids including, but not limited to, hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is effective for venous access in adults, children, and infants who require intravenous therapy.
    Device Description
    BMW Medical has developed a catheter that provides the benefits of the valve incorporated at the distal tip of the Groshong catheter on an open-ended catheter. The BMW valve is external to the central venous system and is protected inside the rigid catheter adapter. BMW Medical, Inc.'s multi-lumen catheters are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO,) prior to extrusion to impart radiopacity. The catheters vary in diameter and number of lumens to accommodate specific applications. A silicone rubber joint permanently attaches the multi-lumen catheter tubing to the 2 or 3 legs required to access each lumen of a dual or a triple lumen catheter. A 2-piece rigid plastic adapter is attached to the proximal end of each single lumen leg. Each leg is mechanically locked onto the barbed end of the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows for attachment of the catheter to a male luer fitting. The adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the catheter is not in use. The valve opens toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens toward the female luer of the proximal hub during aspiration of blood samples.
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    K Number
    K963215
    Device Name
    CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML)
    Manufacturer
    BMW MEDICAL, INC.
    Date Cleared
    1996-11-14

    (90 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMW MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BMW's CVC Midline catheter is designed to establish peripheral venous access for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, and blood products. It is also indicated for blood specimen withdrawal.
    Device Description
    BMW Medical has developed a midline catheter that provides the benefits of the valve incorporated at the distal tip of the Groshong PIC catheter on an open-ended midline catheter. The BMW valve is external to the central venous system and is protected inside the catheter adapter. BMW Medical, Inc.'s midline catheters are single lumen catheters. They are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO2) prior to extrusion to impart radiopacity. The catheters vary in diameter to accommodate specific patient populations. A 2-piece plastic adapter is attached to the proximal end of each single lumen catheter. The catheter is mechanically locked onto the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows attachment of the catheter to a male luer fitting. The adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the catheter is not in use. The valve opens inward toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens outward toward the female luer of the proximal hub during aspiration of blood samples.
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    K Number
    K963097
    Device Name
    CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)
    Manufacturer
    BMW MEDICAL, INC.
    Date Cleared
    1996-10-18

    (70 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMW MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BMW's CVC-PICC is designed to establish peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.
    Device Description
    BMW Medical, Inc.'s peripherally inserted central venous catheters are configured as long-term single lumen catheters. They are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO ) prior to extrusion to impart radiopacity. The catheters vary in length and diameter to accommodate specific patient populations. A 2-piece plastic adapter is attached to the proximal end of each single lumen catheter. The catheter is mechanically locked onto the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows attachment of the catheter to a male luer fitting. The adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the catheter is not in use. The valve opens inward toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens outward toward the proximal hub during aspiration of blood samples.
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    K Number
    K962300
    Device Name
    CLAMPLESS VALVED CATHETER
    Manufacturer
    BMW MEDICAL, INC.
    Date Cleared
    1996-09-05

    (84 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMW MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BMW's central venous catheters are designed for the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as for blood withdrawal.
    Device Description
    BMW Medical has developed a central venous catheter that provides the clampless valve features of the Groshong catheter on an open-ended Hickman catheter. The BMW valve is external to the central venous system and is protected inside an adapter attached to a Hickman-type catheter. This configuration provides the advantages of a normally closed three-way valve while avoiding the influences of the central venous system and continuous direct blood contact that can potentially interfere with the function of the Groshong three-way valve. BMW Medical, Inc.'s central venous catheters are configured as long-term single lumen catheters. They are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO2) prior to extrusion to impart radiopacity. The catheters vary in length and diameter, specific sizes designed for pediatric and adult populations. A 2-piece plastic adapter is attached to the proximal end of each single lumen catheter. The catheter is mechanically locked onto the barbed end of the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows attachment of the catheter to a male luer fitting. The adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the catheter is not in use. The valve opens inward toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens outward toward the proximal hub during aspiration of blood samples. The valve is captured (sandwiched) between the seating surfaces of the two-piece adapter. The seating surfaces of the adapter are held in position and bonded between the proximal (female luer) and distal (barbed) pieces. In addition to central venous catheters. BMW intends to market a surgical tunneler which is used to form a subcutaneous tunnel from the catheter exit site, in the area just below the patient's nipple, to the entrance site near the patients mid-clavicular area.
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