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FDA 510(k)

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

K-Number: K251103 · 2025-05-09

ApplicantPhilips Image Guided Therapy Corporation
Decision Date2025-05-09
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) is a medical device manufactured by Philips Image Guided Therapy Corporation. It received FDA 510(k) clearance on 2025-05-09 under approval number K251103. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Philips Image Guided Therapy Corporation. The 510(k) number is K251103.

When was VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) approved by the FDA?

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

What company makes VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)?

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) is manufactured by Philips Image Guided Therapy Corporation.

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.

Related Clinical Trials

NCT07552272 Hummingbird ICE Study NOT_YET_RECRUITING NCT06808217 A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation ACTIVE_NOT_RECRUITING NCT06011252 Pacing Characteristics of a Conventional Bipolar ACTIVE_NOT_RECRUITING NCT06336655 Physiology of Unloading VA ECMO Trial RECRUITING NCT07531368 BBAP With CS Mapping Guidance NOT_YET_RECRUITING NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING

Other Devices by Philips Image Guided Therapy Corporation

K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter K200410Reconnaissance PV .018 OTW Digital IVUS Catheter K253714IntraSight Plus PMA P180034Scaffold, dissection repair PMA P230021Stent, iliac vein

Related Devices (Code: OBJ)

K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation K160514OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation K161125OptiCross X, 40 MHz Coronary Imaging CatheterBoston Scientific Corporation K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)Boston Scientific Corporation K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)Boston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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