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FDA 510(k)

NorthStar Mapping System (MAP01 or MAP01-01)

K-Number: K261119 · 2026-06-30

ApplicantImricor Medical Systems, Inc.
Decision Date2026-06-30
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NorthStar Mapping System (MAP01 or MAP01-01) 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 2026-06-30 under 510(k) number K261119. 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 (MAP01 or MAP01-01)?

NorthStar Mapping System (MAP01 or MAP01-01) is a medical device that received FDA 510(k) clearance on 2026-06-30. The listed applicant is Imricor Medical Systems, Inc.. The 510(k) number is K261119.

When did NorthStar Mapping System (MAP01 or MAP01-01) receive FDA 510(k) clearance?

NorthStar Mapping System (MAP01 or MAP01-01) received FDA 510(k) clearance on 2026-06-30, under 510(k) number K261119.

Who is the listed applicant for NorthStar Mapping System (MAP01 or MAP01-01)?

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 NorthStar Mapping System (MAP01 or MAP01-01)?

The FDA product code for NorthStar Mapping System (MAP01 or MAP01-01) is DQK.

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.

K252164NorthStar™ Mapping SystemK252794Vision-MR™ Diagnostic Catheter

Related Devices (Code: DQK)

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.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)Centerline Biomedical

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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