Cleared Traditional

XC11 ICE System, USA

K250955 · Yorlabs, Inc. · Cardiovascular

Oct 2025

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K250955 is an FDA 510(k) clearance for the XC11 ICE System, USA, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Yorlabs, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 22, 2025, 205 days after receiving the submission on March 31, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K250955 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2025
Decision Date	October 22, 2025
Days to Decision	205 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.