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FDA 510(k)

SmartGUIDE deflectable hydrophilic guidewire

K-Number: K222690 · 2023-04-24

ApplicantArtiria Medical SA
Decision Date2023-04-24
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06972966NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)COMPLETEDNCT05564325Real-time Deflectable Guidewire in Neuro-interventions StudyTERMINATED

Related Devices (Code: MOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262424Willow 12 GuidewireArbor Endovascular, LLCK260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech LimitedK260537Willow 24 GuidewireArbor Endovascular, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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