FDA 510(k)

Voyager Trajectory Array Guide (V-TAG)

Número K: K180854 · 2018-07-23

Data da decisão2018-07-23

Código do produtoHAW

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: HAW)

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB K253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.