Cleared Traditional

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

K200812 · Philips Image Guided Therapy Corporation · Cardiovascular

Sep 2020

Decision

159d

Days

Class 2

Risk

About This 510(k) Submission

K200812 is an FDA 510(k) clearance for the VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter, 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 September 2, 2020, 159 days after receiving the submission on March 27, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K200812 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 2020
Decision Date	September 02, 2020
Days to Decision	159 days
Submission Type	Traditional
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.