510(k) K221112
K221112 is an FDA 510(k) premarket notification submitted by Biosense Webster, Inc. for the device "CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)". The FDA issued a decision of Substantially Equivalent on August 17, 2022. 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
- August 17, 2022
- Date Received
- April 15, 2022
- 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