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510(k) Data Aggregation
K Number
K222647Device Name
INT Introducer Set
Manufacturer
Date Cleared
2022-09-13
(12 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Kindly Medical Instruments Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Femoral artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the femoral artery while minimizing blood loss during interventional procedures.
Radial Artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wres, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.
Device Description
The Introducer Set is supplied with an introducer sheath, a dilator, a guidewire and an access needle. These devices will be manufactured in 5.0, 6.0, 7.0, and 8.0 French and in lengths of 5, 7 and 11 centimeters. The sets are compatible with the supplied 0.018", 0.021" guidewire and 21G needle in length of 7cm. The sets are supplied sterile and intended for single use.
The sheath shaft and hub are manufactured of Fluorinated ethylene propylene and copolyester; one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hub, color-coded by French size, contains a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The side tube extension may be used for fluid and medication administration, as well as blood sampling.
The dilator is an open, tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire is inserted into the introducer sheath to facilitate and support entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator tubes are manufactured of polypropylene. Dilator tubes are press-fit into the dilator hub with a bushing. The sheath hub and dilator hub lock using a rotating motion.
Introducer Set is designed specifically to introduce therapeutic or diagnostic devices into the vasculature. Using the Seldinger technique, the physician gains percutaneous access to the vascular system and then employs the introducer sheath as a conduit for inserting diagnostic and/or interventional devices into the patient.
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K Number
K201706Device Name
KDL Micro catheter
Manufacturer
Date Cleared
2021-07-22
(395 days)
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Kindly Medical Instruments Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
KDL Micro catheter is used to provide support, to facilitate the placement of guidewires in the peripheral and coronary vasculature, and can be used to exchange one guidewire for another. It is also intended to assist in the delivery of diagnostics, embolic, or therapeutic materials into peripheral and coronary vessels
Device Description
The KDL Micro catheter is available in two French configurations, 2.3F (proximal)/1.6F (distal) and 2.5F (proximal) /1.8F (distal), 110cm, 130cm, 180cm of effective lengths. The proposed device consists of Hub with luer connector, strain relief, catheter shaft, a radiopaque marker and soft tip. The catheter shaft and radiopaque marker consist of 3 layers, an outer layer of Eurelon or pebax tube containing BaSO4, a middle layer of stainless steel braid mesh and an inner layer of PTFE tube, in addition, the middle layer of radiopaque marker consist of Platinoiridium. The radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The soft tip consists of 2 layers, an outer layer of pebax tube containing BaSO4, an inner layer of PTFE tube. The outer surface of the micro catheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the micro catheter into the vasculature.
The distal tip of micro catheter is offered in straight (MCS) and swan neck (MCM) configurations.
All models of the catheter are designed to accept a maximum guidewire diameter of 0.010 inch or 0.014 inch.
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K Number
K201929Device Name
KDL Angiography Catheter
Manufacturer
Date Cleared
2021-05-14
(308 days)
Product Code
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Kindly Medical Instruments Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
KDL Angiography Catheter are intended for delivery of radiopaque contrast media to selected sites during the angiography procedure of the peripheral and coronary vascular system.
Device Description
The proposed device consists of tube hub, strain relief, catheter shaft with stainless steel braid layer, soft extension and distal tip. The catheter shaft is made of Pebax contain Barium Sulfate that is radiopaque and a middle stainless steel braid layer. Soft extension and distal tip is made of Pebax contain Barium Sulfate without stainless steel braid layer that could prevent vascular injury when pushed into the blood vessel.
The distal tip of the catheter is available in 32 kinds tip shape configurations. The outer diameter is available in 4F, 5F, 6F, 7F sizes and the length is available in 100cm except for Pig angiography catheter in length of 110cm. The side hole on distal tip is used to disperse the contrast media and balance pressure.
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K Number
K201601Device Name
Medical Face Mask
Manufacturer
Date Cleared
2020-11-10
(151 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Kindly Medical Instruments Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material.
Device Description
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K Number
K180177Device Name
Guidewire
Manufacturer
Date Cleared
2018-09-13
(234 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Kindly Medical Instruments Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Guidewire is intended to be used in the coronary and/or peripheral vascular system to introduce and position catheters to desired anatomical location during diagnostic or interventional procedures.
Device Description
The Guidewire are designed to facilitate the placement of interventional devices. The guidewire has two models. PTFE coating type and hydrophilic coating type. The two models have the different material for wire and coating. PTFE guidewire consists of stainless steel spring coil wire, inside core wire and a safety wire. The guidewire is placed inside a loop flush dispenser, also as a hoop. Hydrophilic guidewire consisits of nickel titanium alloys core wire with a jacket that has a hydrophilic coating. The guidewire is placed inside a spiral hoop. The Guidewire is radiopactitive under fluoroscopy. The wire will be offered in straight, angle, J-tip configuration . All guidewires are available in five nominal outer diameter of 0.025", 0.028", 0.032", 0.038"inches and nominal lengths of 100cm, 150cm, 180cm, and 260cm.
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K Number
K180178Device Name
Introducer Set
Manufacturer
Date Cleared
2018-09-10
(231 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Kindly Medical Instruments Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Femoral artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through artery while minimizing blood loss during interventional procedures.
Radial Artery Introducer Set. The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.
Device Description
This set classifies two types: Femoral Artery and Radial Artery. The Femoral Artery introducer set consist of a sheath introdcuer, dilator, needle, Guidewire. The Radial Artery introducer set consist of a sheath introdcuer lubricated with/without hydrophilic coating, dilator, I.V. cannula /Introducer needle,Guidewire (with/without hydrophilic coating).
The Introducer Set consists of sheath introducer, each packaged in a set to together with a dilator, introdcuer needle, and guidewire. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with tubing connected to a 3-way stopcocks is used for injection contrast medium. The dilator is provided to aid in the introduction of sheath to the target vessel. The Introducer needle/I.V. Cannula is provided a conduit for insertion of the guidewire into the vascular system. The guidewire is utilized as a guiding mechanism for the introducer sheath into the vascular system.
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