Cleared Special

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

K251103 · Philips Image Guided Therapy Corporation · Cardiovascular

May 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K251103 is an FDA 510(k) clearance for the VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D), a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Philips Image Guided Therapy Corporation (San Diego, US). The FDA issued a Cleared decision on May 9, 2025, 28 days after receiving the submission on April 11, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K251103 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2025
Decision Date	May 09, 2025
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	OBJ — Catheter, Ultrasound, Intravascular
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1200
Definition	For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.