510(k) K240366
EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter by
Boston Scientific Corporation
— Product Code DRF
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2024
- Date Received
- February 6, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type