NorthStar Mapping System (MAP01 or MAP01-01)— 510(k) K261119
Substantially EquivalentImricor 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.
Summary
Imricor Medical Systems' NorthStar Mapping System is listed under two model numbers, MAP01 or MAP01-01, and is filed under DQK, programmable diagnostic computers. The record doesn't say how the two model numbers differ.
Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).
Imricor filed from Burnsville, Minnesota. Review took 88 calendar days (April 3 to June 30, 2026).
Clearance details
- Applicant
- Imricor Medical Systems, Inc.
- Product code
- Product code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Burnsville, MN, US
Recent devices under product code DQK
view allMore clearances from Imricor Medical Systems, Inc.
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . 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.