Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Voyager Therapeutics, Inc.. It received FDA 510(k) clearance on 2018-07-23 under 510(k) 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. The listed applicant is Voyager Therapeutics, Inc.. The 510(k) number is K180854.

When did Voyager Trajectory Array Guide (V-TAG) receive FDA 510(k) clearance?

Voyager Trajectory Array Guide (V-TAG) received FDA 510(k) clearance on 2018-07-23, under 510(k) number K180854.

Who is the listed applicant for Voyager Trajectory Array Guide (V-TAG)?

The FDA 510(k) record lists Voyager Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 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.

NCT07764146An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's DiseaseNOT_YET_RECRUITING

Related Devices (Code: HAW)

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.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

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.

↑