Imricor Medical Systems, Inc. · Class II · Cleared Jan 8, 2026
| K-number | K252794 |
| Device name | Vision-MR Diagnostic Catheter |
| Applicant | Imricor Medical Systems, Inc. |
| Product code | DRF |
| Device class | Class II |
| Decision date | Jan 8, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1220 |
The Vision-MR Diagnostic Catheter is a 9F steerable diagnostic catheter with two gold electrodes designed for cardiac electrophysiological mapping (stimulating and recording) during electrophysiology procedures in patients age 18 and older. It is used to diagnose arrhythmias and guide therapeutic decisions, and must be used with the Advantage-MR EP Recorder/Stimulator System.
The device is an MR Conditional 9F (3.0 mm) uni-directional deflectable catheter, 115 cm in length, with a tip electrode (1.5 mm) and ring electrode (1.4 mm) spaced 1.3 mm apart. It features a receive coil for MR tracking and a thumb control handle for deflection. The catheter is composed of flexible polymers with precious metal electrodes and is sterilized via 2x EO sterilization. While primarily intended for MR environments, it can also be used in conventional fluoroscopy laboratories.
ISO 11607-1 (packaging sterility); bioburden and endotoxin testing; design verification testing at baseline (T=0) and 24-month real-time aging to support labeled shelf life; packaging design verification testing.
The Vision-MR is substantially equivalent to the predicate EP XT Steerable Diagnostic Catheter because both devices share identical indications for use, material construction, sterilization method, procedure type, and patient population. Both are uni-directional diagnostic catheters with the same control mechanism, composed of flexible polymers ending in precious metal tips. The differences in the subject device (MR conditional capability) do not raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov