# K252794: Vision-MR™ Diagnostic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Imricor Medical Systems, Inc.
- Decided: Jan 8, 2026 after 128 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K240366 (2024). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240366: EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter, Boston Scientific Corporation (2024) Summary page 5.

## Most influential descendants
- K261119: NorthStar Mapping System (MAP01 or MAP01-01) (2026), 0 descendants of its own

## Indications for use
The Vision-MR Diagnostic Catheter is intended for cardiac electrophysiological mapping (stimulating and recording) during electrophysiology procedures to diagnose arrhythmias and/or guide therapeutic decisions in patients age 18 years or older.

Source page: https://510kreport.com/device/K252794
Methodology: https://510kreport.com/methodology