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510(k) Data Aggregation

    K Number
    K212719
    Device Name
    Micro Catheter and Guidewire System
    Date Cleared
    2022-04-11

    (227 days)

    Product Code
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Hengrui Hongyuan 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 vessels. The Micro Catheter and Guidewire system is also infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The system should not be used in cerebral vessels.
    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, a torque device and a peel-able tube. The catheter is consist of a hub, a stress relief tube and a catheter shaft. The catheter shaft 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 polyamide. There is also a hydrophilic coating on the catheter surface. The guidewire is consist of a nitinol core, a polymer jacket with PVP hydrophilic coating over its entire surface, and a spring coil at distal. It has a white marker at the proximal to indicate the length inserted into human body and its relative position with the catheter.
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    K Number
    K210562
    Device Name
    HRSpheres Narrow-Size Embolic Microspheres
    Date Cleared
    2021-10-01

    (218 days)

    Product Code
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Hengrui Hongyuan Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HRSpheres Narrow-Size Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.
    Device Description
    HRSpheres Narrow-Size Embolic Microspheres are compressible hydrogel microspheres with a regular shape, smooth surface, and calibrated size, which are formed as a result of chemical modification on polyvinyl alcohol (PVA) materials. HRSpheres Narrow-Size Embolic Microspheres consist of a macromer derived from PVA, and are hydrophilic, non-resorbable, and are available in a variety of diameters ranging from 70 - 1,200 um. The preservation solution is 0.9% sodium chloride solution. The water content of a fully polymerized microsphere is 91% ~ 94%. Microspheres are compressible to enable smooth delivery through the indicated delivery catheter. The HRSpheres are available in dyed (blue) and clear (undyed with natural color). Blue-dyed microspheres aid in the visualization of the microspheres in the delivery syringe. HRSpheres Narrow-Size Embolic Microspheres are packaged in sterile sealed glass vials for single use only and available with 1 mL, 2 mL, or 3 mL microspheres volumes per vial. HRSpheres Narrow-Size Embolic Microspheres can be delivered to a targeted area through typical microcatheters in the 1.7 – 4 Fr range. By blocking the blood supply to the target area, the tumor or malformation is starved of nutrients and shrinks in size. At the time of use. HRSpheres Narrow-Size Embolic Microspheres are mixed with a nonionic contrast agent to form a suspension solution and aid in visualization during a procedure.
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