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510(k) Data Aggregation

    K Number
    K102833
    Device Name
    DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
    Manufacturer
    FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
    Date Cleared
    2011-11-18

    (415 days)

    Product Code
    MPB
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein.
    Device Description
    Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein. It consists of a catheter, a puncture needle, a guide wire and a dilator. The set is provided EO sterilized.
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    K Number
    K070451
    Device Name
    ABLE CENTRAL VENOUS CATHETER
    Manufacturer
    FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
    Date Cleared
    2007-07-31

    (166 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Central Venous Catheters including: 14 G, 16 G, 18 G, and 20 G in single-lumen catheters; 4 F. 5 F, 7 F and 8 F in double-lumen catheter; 5.5 F and 7 F in triple-lumen catheter; are intended for vascular access infusion and withdrawal of blood, blood products, and fluids, plasma pheresis, hyperalimentation, central venous blood sampling and continuous and intermittent drug infusion.
    Device Description
    Able® Central Venous Catheter is a polyurethane central venous catheter which is intended to insert into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. All the variants of applicant devices: single-lumen, and triple-lumen, and triple-lumen. There are outer diameter dimensions of 14 G, 16 G, 18 G, and 20 G in single-lumen catheters, 4 F, 5 F, 7 F and 8 F in double-lumen catheter, and 5.5 F and 7 F in triple-lumen catheter. The applicant device mainly consists of 5 parts: distal end, catheter body of effective length, catheter junction, extension cannula, and catheter hub. Distal end is soft and flexible, which is intended to be located within the patient's vena cava. Catheter body of effective length is tubular and with no-communication single or multiple lumens. Catheter junction attaches catheter body of effective length and extension cannula. At the end of the extension cannula, there is female catheter hub for the connection.
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