NorthStar™ Mapping System
FDA 510(k) clearance K252164 · decided 2026-01-28
Clearance details
- K-number
- K252164
- Device name
- NorthStar™ Mapping System
- Applicant
- Imricor Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2025-07-10
- Decision date
- 2026-01-28
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Burnsville, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.