FDA AI Clearance Tracker/K252972
Cardiovascular · 510(k)
CARTO 3 EP Navigation System V8.4
Biosense Webster, Inc.
About this listing
CARTO 3 EP Navigation System V8.4 from Biosense Webster, Inc. appears on the U.S. FDA list of AI-enabled medical devices under submission K252972. It went through the 510(k) pathway, reviewed by the Cardiovascular panel, with an FDA decision dated February 20, 2026. Its primary FDA product code is DQK.
The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.
- Device
- CARTO 3 EP Navigation System V8.4
- Company
- Biosense Webster, Inc.
- Submission number
- K252972
- Pathway
- 510(k)
- Decision date
- Feb 20, 2026
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- DQK
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Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.