Traxcess 14 SELECT Guidewire
K-Number: K200547 · 2020-04-16
ApplicantMicroVention, Inc.
Decision Date2020-04-16
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Traxcess 14 SELECT Guidewire is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2020-04-16 under approval number K200547. 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 Traxcess 14 SELECT Guidewire?
Traxcess 14 SELECT Guidewire is a medical device that received FDA 510(k) clearance on 2020-04-16. It is manufactured by MicroVention, Inc.. The 510(k) number is K200547.
When was Traxcess 14 SELECT Guidewire approved by the FDA?
Traxcess 14 SELECT Guidewire received FDA 510(k) clearance on 2020-04-16, under approval number K200547.
What company makes Traxcess 14 SELECT Guidewire?
Traxcess 14 SELECT Guidewire is manufactured by MicroVention, Inc..
What is the FDA product code for Traxcess 14 SELECT Guidewire?
The FDA product code for Traxcess 14 SELECT 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.