510(k) K230253
K230253 is an FDA 510(k) premarket notification submitted by Biosense Webster, Inc. for the device "OPTRELL Mapping Catheter with TRUEref Technology". The FDA issued a decision of Substantially Equivalent on March 2, 2023. The device falls under product code MTD (Catheter, Intracardiac Mapping, High-Density Array), a Class II device regulated under 21 CFR 870.1220. Biosense Webster, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2023
- Date Received
- January 31, 2023
- Clearance Type
- Special
- 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