Voyager Trajectory Array Guide (V-TAG)
K-Number: K180854 · 2018-07-23
ApplicantVoyager Therapeutics, Inc.
Decision Date2018-07-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Voyager Trajectory Array Guide (V-TAG) is a medical device manufactured by Voyager Therapeutics, Inc.. It received FDA 510(k) clearance on 2018-07-23 under approval number K180854. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Voyager Trajectory Array Guide (V-TAG)?
Voyager Trajectory Array Guide (V-TAG) is a medical device that received FDA 510(k) clearance on 2018-07-23. It is manufactured by Voyager Therapeutics, Inc.. The 510(k) number is K180854.
When was Voyager Trajectory Array Guide (V-TAG) approved by the FDA?
Voyager Trajectory Array Guide (V-TAG) received FDA 510(k) clearance on 2018-07-23, under approval number K180854.
What company makes Voyager Trajectory Array Guide (V-TAG)?
Voyager Trajectory Array Guide (V-TAG) is manufactured by Voyager Therapeutics, Inc..
What is the FDA product code for Voyager Trajectory Array Guide (V-TAG)?
The FDA product code for Voyager Trajectory Array Guide (V-TAG) is HAW.
Related Devices (Code: HAW)
K162604Cranial Reducing TubesMedtronic Navigation, Inc.
K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation
K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc.
K152764EXACTECH GPSBlue Ortho
K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc.
K151156Fiagon Navigation SystemFiagon GmbH
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.