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FDA 510(k)

NorthStar™ Mapping System

K-Number: K252164 · 2026-01-28

ApplicantImricor Medical Systems
Decision Date2026-01-28
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NorthStar™ Mapping System is a medical device manufactured by Imricor Medical Systems. It received FDA 510(k) clearance on 2026-01-28 under approval number K252164. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NorthStar™ Mapping System?

NorthStar™ Mapping System is a medical device that received FDA 510(k) clearance on 2026-01-28. It is manufactured by Imricor Medical Systems. The 510(k) number is K252164.

When was NorthStar™ Mapping System approved by the FDA?

NorthStar™ Mapping System received FDA 510(k) clearance on 2026-01-28, under approval number K252164.

What company makes NorthStar™ Mapping System?

NorthStar™ Mapping System is manufactured by Imricor Medical Systems.

What is the FDA product code for NorthStar™ Mapping System?

The FDA product code for NorthStar™ Mapping System is DQK.

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Related Devices (Code: DQK)

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Official Source

View on FDA Database →

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

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