510(k) K231207
K231207 is an FDA 510(k) premarket notification submitted by Biosense Webster, Inc. for the device "CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)". The FDA issued a decision of Substantially Equivalent on September 7, 2023. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Biosense Webster, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 2023
- Date Received
- April 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type