NorthStar Mapping System (MAP01 or MAP01-01)

Q: What is the product code of K261119?

The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.

FDA 510(k) K261119 · Imricor Medical Systems, Inc.

Substantially Equivalent

510(k) numberK261119

Submission

Device name: NorthStar Mapping System (MAP01 or MAP01-01)
Applicant: Imricor Medical Systems, Inc.
Burnsville, MN, US
Received: April 3, 2026
Decision date: June 30, 2026
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DQK – Computer, Diagnostic, Programmable
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1425
Specialty: Cardiovascular

Other 510(k)s with product code DQK

510(k)	Device	Applicant	Decision
K262005	Affera Integrated Mapping SystemDQK · Special	Medtronic, Inc.	08/21/2026SE
K253692	AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional	Boston Scientific	08/21/2026SE
K253576	CorVista System® with PCWP Add-OnDQK · Traditional	Analytics For Life, Inc.	07/26/2026SE
K262006	EnSite X EP SystemDQK · Special	Abbott Medical	07/15/2026SE
K252978	ScioCardio ECG Analysis PlatformDQK · Traditional	Synergen Technology Labs, LLC	07/09/2026SE
K253463	ILR ECG Analyzer (IM007)DQK · Traditional	Implicity, Inc.	07/02/2026SE
K253088	OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional	Micropace Pty, Ltd.	06/12/2026SE
K261329	Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special	Centerline Biomedical	06/10/2026SE
K252859	ZEUS Platform (FG0501US)DQK · Traditional	iRhythm Technologies, Inc.	05/29/2026SE
K260212	EnSite X EP SystemDQK · Traditional	Abbott Medical	04/20/2026SE

More from Abbott Medical

510(k)	Device	Decision
K252164	NorthStar Mapping SystemDQK · Traditional	01/28/2026SE
K252794	Vision-MR Diagnostic CatheterDRF · Traditional	01/08/2026SE

Questions and answers

When was NorthStar Mapping System (MAP01 or MAP01-01) cleared by the FDA?

NorthStar Mapping System (MAP01 or MAP01-01) (K261119) received a 510(k) decision of Substantially Equivalent on June 30, 2026, 88 days after the submission was received.

What is the product code of K261119?

The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.