510(k) K211438
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2022
- Date Received
- May 10, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intracardiac Mapping, High-Density Array
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type