FDA 510(k)

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

Numéro K : K200812 · 2020-09-02

DemandeurPhilips Image Guided Therapy Corporation

Date de décision2020-09-02

Code produitOBJ

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Philips Image Guided Therapy Corporation en tant que demandeur

K253714IntraSight Plus K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)K200410Reconnaissance PV .018 OTW Digital IVUS Catheter

Dispositifs connexes (Code : 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.

Source officielle

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