NorthStar Mapping System (MAP01 or MAP01-01)— 510(k) K261119

Name: FDA 510(k) clearance K261119
Creator: U.S. Food and Drug Administration
Published: 2026-06-30

Substantially Equivalent

Imricor Medical Systems, Inc.

FDA 510(k) clearance K261119 for NorthStar Mapping System (MAP01 or MAP01-01), Substantially Equivalent on 2026-06-30. Applicant: Imricor Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Imricor Medical Systems, Inc.
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2026-04-03
Decision date: 2026-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Burnsville, MN, US

Download summary PDF View on FDA.gov ↗

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K253692 — AVVIGO+ Multi-Modality Guidance System2026-08-21
K262005 — Affera Integrated Mapping System2026-08-21
K253576 — CorVista System® with PCWP Add-On2026-07-26
K262006 — EnSite X EP System2026-07-15
K252978 — ScioCardio ECG Analysis Platform2026-07-09

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K252794 — Vision-MR Diagnostic Catheter2026-01-08

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.