FDA 510(k)

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter

Número K: K200812 · 2020-09-02

RequerentePhilips Image Guided Therapy Corporation

Data da decisão2020-09-02

Código do produtoOBJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Philips Image Guided Therapy Corporation. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K200812. 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 VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter?

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Philips Image Guided Therapy Corporation. The 510(k) number is K200812.

When did VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter receive FDA 510(k) clearance?

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter received FDA 510(k) clearance on 2020-09-02, under 510(k) number K200812.

Who is the listed applicant for VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter?

The FDA 510(k) record lists Philips Image Guided Therapy Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter?

The FDA product code for VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE 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 Philips Image Guided Therapy Corporation como candidato(a)

K253714IntraSight Plus K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)K200410Cáteter Digital IVUS Reconnaissance PV .018 OTW

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.