FDA 510(k)

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

Número K: K200195 · 2020-06-22

Data da decisão2020-06-22

Código do produtoOBJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Northeast Scientific, Inc.. It received FDA 510(k) clearance on 2020-06-22 under 510(k) number K200195. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NES Reprocessed Visions PV .014P RX Digital IVUS Catheter?

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2020-06-22. The listed applicant is Northeast Scientific, Inc.. The 510(k) number is K200195.

When did NES Reprocessed Visions PV .014P RX Digital IVUS Catheter receive FDA 510(k) clearance?

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter received FDA 510(k) clearance on 2020-06-22, under 510(k) number K200195.

Who is the listed applicant for NES Reprocessed Visions PV .014P RX Digital IVUS Catheter?

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

What is the FDA product code for NES Reprocessed Visions PV .014P RX Digital IVUS Catheter?

The FDA product code for NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is OBJ.

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

Outros registros que listam Northeast Scientific, Inc. como candidato(a)

K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

Dispositivos Relacionados (Código: OBJ)

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited K252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston Scientific K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device K250955XC11 ICE System, USAYorlabs, Inc.

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.