FDA 510(k)

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)

Numéro K : K251103 · 2025-05-09

DemandeurPhilips Image Guided Therapy Corporation

Date de décision2025-05-09

Code produitOBJ

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) 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 2025-05-09 under 510(k) number K251103. 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 Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)?

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Philips Image Guided Therapy Corporation. The 510(k) number is K251103.

When did VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) receive FDA 510(k) clearance?

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) received FDA 510(k) clearance on 2025-05-09, under 510(k) number K251103.

Who is the listed applicant for VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)?

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 Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)?

The FDA product code for VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) is OBJ.

Essais cliniques associés

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

K253714IntraSight Plus K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter 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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