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510(k) Data Aggregation

    K Number
    K172331
    Device Name
    Type I, Type II, Type III, Type IV
    Date Cleared
    2018-03-02

    (212 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lepu Medical Technology (Beijing) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Brilliant Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.
    Device Description
    The Brilliant™ Introducer Kit classifies into four types (Type I, II, III, and IV). Type I consists of a sheath introducer and a dilator. Type II consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator and a puncture needle. Type III consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator. Type IV consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator, an Intravascular catheter (with needle) and a syringe. The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide wires, model dependent, are utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle or the intravascular catheter. The guide wire is radio- detective under fluoroscopy. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vasculature. The main components of the sheath introducer assembly are a hydrophilic coated sheath introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The hydrophilic coated dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. The sheath introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy. There is no radiocontrast agent in the dilator.
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    K Number
    K172099
    Device Name
    Shoocin Introducer Kit
    Date Cleared
    2017-10-05

    (86 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lepu Medical Technology (Beijing) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ShoocinTM Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.
    Device Description
    The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer Sheath into the vascular system. The Guide Wire contains a wire collimator, which assists in funneling the wire through the lumen of the Puncture Needle. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The Dilator is used to provide support and stability to the Sheath Introducer during deployment into the vascular system. The proximal end of the Dilator includes a luer port and has a tapered, atraumatic distal tip. There is no radiocontrast agent on the dilator.
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    K Number
    K141707
    Device Name
    ULTRASKIN HYDROPHILIC GUIDE WIRE
    Date Cleared
    2015-01-21

    (211 days)

    Product Code
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ULTRASKIN™ Hydrophilic Guide Wire is indicated to direct a catheter to the desired peripheral or coronary anatomical location during diagnostic or interventional procedure.
    Device Description
    The ULTRASKIN™ Hydrophilic Guide Wire consists of a Nitinol core wire, a plastic jacket with hydrophilic coating. The wire distal curve comes in different shapes such as straight, J angled and angled. The guide wire is radiopactitive under fluoroscopy.
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    K Number
    K142359
    Device Name
    Vasc Band hemostat
    Date Cleared
    2014-10-23

    (59 days)

    Product Code
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lepu Medical Technology (Beijing) Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.
    Device Description
    Vasc Band hemostat (Vasc Band) is a compression device that applies mechanical pressure to achieve hemostasis of vascular access sites. Vasc Band consists of an adjustable retention strap, inflatable compression balloon, inflation tube, and an inflation valve. A 22 ml inflation syringe is also included with the device. Vasc Band is available in five band lengths: 21 cm, 27 cm, 29 cm, and 37 cm.
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    K Number
    K123475
    Device Name
    SHOOCIN INTRODUCER KIT
    Date Cleared
    2014-02-03

    (447 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ShoocinTM Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.
    Device Description
    The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. The puncture needle incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The flexible stainless steel guide wire is utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle and contains marking that are visible under fluoroscopy, which can determine in length of the guide wire within the vascular system. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated sheath introducer, hemostasis valve housing, and a side port with tubing connected to a 3-way stopcock/valve. The dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.
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    K Number
    K123473
    Device Name
    HOPER PTCA BALLOON CATHETER
    Date Cleared
    2013-08-13

    (273 days)

    Product Code
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. This balloon dilatation catheter is not intended for the expansion or delivery of a stent.
    Device Description
    Hoper Rapid Exchange (LPRX) Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The proximal shaft is a polymer coated stainless steel tube. The steel construction is designed to optimize proximal pushability with a smooth transition to a distal shaft specifically designed to be highly trackable. The semi-compliant balloon material allows dilatation with precise control of balloon diameter and length. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guide wire. The proximal part of the guide wire enters the catheter's tip and advances coaxially out the catheter's proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guide wire. Two marked sections are located on the hypo tube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements. The product can be used to expand stenotic coronary vessel, and improve myocardial bleeding. This kind of balloon catheter possesses such merits as moderate compliance, high pressure resistance, minor diameter, etc.
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    K Number
    K111837
    Device Name
    RADIAL ARTERY COMPRESSION TOURNIQUET
    Date Cleared
    2011-09-27

    (90 days)

    Product Code
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Radial Artery Compression Tourniquet Device is a compression device to assist haemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, haemodialysis, and in patients on anticoagulation therapy.
    Device Description
    The Radial Artery Compression Tourniquet devices consist of a plastic belt with an adjustable fastener on each end, two compression balloons, tubing and a unilateral valve. The plastic belt has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist and are made of clear plastic which allows the physician to view the access site during the haemostasis process. The inflation device introduces air through the unilateral valve filling two compression balloons (large and small) at the same time. The top small balloon is layered and internally connected to the bottom large balloon. The result of the balloon inflation is the haemostasis of the puncture site within the patient's wrist.
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