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

FDA 510(k) K251103 · Philips Image Guided Therapy Corporation

Substantially Equivalent

510(k) numberK251103

Submission

Device name
VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)
Applicant
Philips Image Guided Therapy Corporation
San Diego, CA, US
Received
April 11, 2025
Decision date
May 9, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OBJ – Catheter, Ultrasound, Intravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

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Questions and answers

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

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) (K251103) received a 510(k) decision of Substantially Equivalent on May 9, 2025, 28 days after the submission was received.

What is the product code of K251103?

The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.