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510(k) Data Aggregation
K Number
K172331Device Name
Type I, Type II, Type III, Type IV
Manufacturer
Date Cleared
2018-03-02
(212 days)
Product Code
Regulation Number
870.1340Why 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
K172099Device Name
Shoocin Introducer Kit
Manufacturer
Date Cleared
2017-10-05
(86 days)
Product Code
Regulation Number
870.1340Why 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
K141707Device Name
ULTRASKIN HYDROPHILIC GUIDE WIRE
Manufacturer
Date Cleared
2015-01-21
(211 days)
Product Code
Regulation Number
870.1330Why 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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