Cleared Traditional

Vision-MR? Diagnostic Catheter

K252794 · Imricor Medical Systems, Inc. · Cardiovascular

Jan 2026

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K252794 is an FDA 510(k) clearance for the Vision-MR? Diagnostic Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Imricor Medical Systems, Inc. (Burnsville, US). The FDA issued a Cleared decision on January 8, 2026, 128 days after receiving the submission on September 2, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K252794 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2025
Decision Date	January 08, 2026
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1220