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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 the device name listed in this FDA 510(k) record. The listed applicant is Imricor Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-01-08 under 510(k) 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. The listed applicant is Imricor Medical Systems, Inc.. The 510(k) number is K252794.

When did Vision-MR™ Diagnostic Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Vision-MR™ Diagnostic Catheter?

The FDA 510(k) record lists Imricor Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Imricor Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261119NorthStar Mapping System (MAP01 or MAP01-01)K252164NorthStar™ Mapping System

Related Devices (Code: DRF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationPMA P990025CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDINGBiosense Webster, Inc.K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

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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