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

FDA 510(k) K200812 · Philips Image Guided Therapy Corporation

Substantially Equivalent

510(k) numberK200812

Submission

Device name
VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter
Applicant
Philips Image Guided Therapy Corporation
San Diego, CA, US
Received
March 27, 2020
Decision date
September 2, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 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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K261696ACUNAV Luxera 4D ICE CatheterOBJ · Special Siemens Medical Solutions USA, Inc.09/10/2026SE
K261849VERAFEYE Imaging Catheter (VF-VIC-002)OBJ · Special Luma Vision Limited07/24/2026SE
K252945Novasight Hybrid SystemOBJ · Traditional Conavi Medical, Inc.04/17/2026SE
K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter…OBJ · Special Boston Scientific04/08/2026SE
K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterOBJ · Special Volcano Corporation (Dba Philips Image Guided…10/28/2025SE
K250955XC11 ICE System, USAOBJ · Traditional Yorlabs, Inc.10/22/2025SE
K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemOBJ · Traditional Jiangsu Tingsn Technology Co., Ltd.07/19/2025SE
K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…OBJ · Special Abbott Medical05/23/2025SE
K251231ViewFlex™ X ICE Catheter, Sensor Enabled™OBJ · Special Abbott Medical05/20/2025SE
K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac…OBJ · Special Philips Image Guided Therapy Corporation05/09/2025SE

More from Philips Image Guided Therapy Corporation

510(k)DeviceDecision
K253714IntraSight PlusIYO · Traditional 02/24/2026SE
K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac…OBJ · Special 05/09/2025SE
K200410Reconnaissance PV .018 OTW Digital IVUS CatheterOBJ · Traditional 05/22/2020SE

Questions and answers

When was VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter cleared by the FDA?

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter (K200812) received a 510(k) decision of Substantially Equivalent on September 2, 2020, 159 days after the submission was received.

What is the product code of K200812?

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