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510(k) Data Aggregation
K Number
K222690Device Name
SmartGUIDE deflectable hydrophilic guidewire
Manufacturer
Artiria Medical SA
Date Cleared
2023-04-24
(230 days)
Product Code
MOF, DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Artiria Medical SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SmartGUIDE guidewire is intended for general intravascular and peripheral vascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. SmartGUIDE is intended to be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Device Description
SmartGUIDE is a deflectable quidewire for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. The device is available with a nominal outer diameter of 0.014" (0.36 mm) and overall length of 200 cm. The device is available sterile and is for single use only.
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