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FDA 510(k)

Vision-MR™ Diagnostic Catheter

K-Number: K252794 · 2026-01-08

ApplicantImricor Medical Systems, Inc.
Decision Date2026-01-08
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vision-MR™ Diagnostic Catheter is a medical device manufactured by Imricor Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-01-08 under approval number K252794. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vision-MR™ Diagnostic Catheter?

Vision-MR™ Diagnostic Catheter is a medical device that received FDA 510(k) clearance on 2026-01-08. It is manufactured by Imricor Medical Systems, Inc.. The 510(k) number is K252794.

When was Vision-MR™ Diagnostic Catheter approved by the FDA?

Vision-MR™ Diagnostic Catheter received FDA 510(k) clearance on 2026-01-08, under approval number K252794.

What company makes Vision-MR™ Diagnostic Catheter?

Vision-MR™ Diagnostic Catheter is manufactured by Imricor Medical Systems, Inc..

What is the FDA product code for Vision-MR™ Diagnostic Catheter?

The FDA product code for Vision-MR™ Diagnostic Catheter is DRF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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