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510(k) Data Aggregation
K Number
K240871Device Name
Synxess Neurovascular Guidewire
Manufacturer
Enlight Medical Technologies (Shenzhen) Co., Ltd.
Date Cleared
2024-11-18
(234 days)
Product Code
MOF
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Enlight Medical Technologies (Shenzhen) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synxess Neurovascular Guidewire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guidewire is intended for use only in the neuro vasculature.
Device Description
The Synxess Neurovascular Guidewire is available in diameters of 0.014 inch (0.35 mm) and 0.010 inch (0.25 mm) and has 200 cm length. The device is comprised of a core wire, coils, and coatings, and is supplied with a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The device is provided sterile and is for single use.
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