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510(k) Data Aggregation
K Number
K193653Device Name
Hydrophilic Coating Guide Wire
Manufacturer
Date Cleared
2020-08-26
(240 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Hengrui Disheng Medical Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Hydrophilic Coating Guide Wire is designed to direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular interventions.
Device Description
The Hydrophilic Coating Guide Wire consists of a Nickel-Titanium alloy core wire; a polymer jacket (Polyurethane containing Tungsten for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The guide wire is provided sterile (EtO) and is intended for single use only.
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K Number
K193647Device Name
Superpipe Angiographic Catheter
Manufacturer
Date Cleared
2020-07-29
(212 days)
Product Code
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Hengrui Disheng Medical Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SUPERPIPE Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system.
Device Description
Angiographic Catheter consists of a catheter hub, a strain relief tubing, catheter shaft (including braided section and non-braided section) and catheter tip. It is comprised of a two-layer construction featuring stainless steel mesh sandwiched between layers of polyamide elastomers of the catheter braided section. The non-braided section is comprised of layers of polyamide elastomers. And the soft catheter tip is comprised of the mixture of polyurethane and polyamide elastomers. The device is offered in lengths of 80cm, 100cm and 110cm.
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K Number
K171665Device Name
Microcatheter and guide-wire system
Manufacturer
Date Cleared
2018-01-11
(220 days)
Product Code
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Hengrui Disheng Medical Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Micro Catheter and Guidewire System is intended for the infusion of contrast media into the peripheral vasculature. The Micro Catheter and Guidewire system is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis.
Device Description
Micro Catheter and Guidewire System consists of a catheter, a guidewire, and accessories. The accessories include a flushing device, a shaping mandrel, an insertion tool, and a torque device. The catheter is consist of a hub, a stress relief tube and a catheter body. The catheter body has three layers. The inner layer is a PTFE tube, the middle layer is consist of stainless steel wire reinforce and platinum-iridium alloy radiopaque distal marker, and the outer layer is polyamides of different hardness mixed with pigment. There is also a hydrophilic coating on the catheter surface. The guidewire is consist of a nitinol core, a polymer jacket with hydrophilic coating over its entire surface and a radiopaque distal marker. It has a white marker at the proximal end to indicate the length inserted into human body and its relative position with the catheter.
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