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 a medical device manufactured by Artiria Medical SA. It received FDA 510(k) clearance on 2023-04-24 under approval 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. It is manufactured by Artiria Medical SA. The 510(k) number is K222690.
When was SmartGUIDE deflectable hydrophilic guidewire approved by the FDA?
SmartGUIDE deflectable hydrophilic guidewire received FDA 510(k) clearance on 2023-04-24, under approval number K222690.
What company makes SmartGUIDE deflectable hydrophilic guidewire?
SmartGUIDE deflectable hydrophilic guidewire is manufactured by Artiria Medical SA.
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.