FDA 510(k)

SmartGUIDE deflectable hydrophilic guidewire

K-Nummer: K222690 · 2023-04-24

Entscheidungsdatum2023-04-24

ProduktcodeMOF

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

SmartGUIDE deflectable hydrophilic guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Artiria Medical SA. It received FDA 510(k) clearance on 2023-04-24 under 510(k) number K222690. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the SmartGUIDE deflectable hydrophilic guidewire?

SmartGUIDE deflectable hydrophilic guidewire is a medical device that received FDA 510(k) clearance on 2023-04-24. The listed applicant is Artiria Medical SA. The 510(k) number is K222690.

When did SmartGUIDE deflectable hydrophilic guidewire receive FDA 510(k) clearance?

SmartGUIDE deflectable hydrophilic guidewire received FDA 510(k) clearance on 2023-04-24, under 510(k) number K222690.

Who is the listed applicant for SmartGUIDE deflectable hydrophilic guidewire?

The FDA 510(k) record lists Artiria Medical SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartGUIDE deflectable hydrophilic guidewire?

The FDA product code for SmartGUIDE deflectable hydrophilic guidewire is MOF.

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Verwandte Geräte (Code: MOF)

K254181Aristotle 65 MacrowireScientia Vascular K26075135 Helix GuidewirePiraeus Medical, Inc.K262424Willow 12 GuidewireArbor Endovascular, LLC K260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristote 14 Guidewire; Aristote 18 Guidewire; Aristote 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.

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