510(k) K240366
K240366 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
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