DeviceClearance

CARTO 3 EP Navigation System V8.4— 510(k) K252972

Substantially Equivalent

Biosense Webster, Inc.

FDA 510(k) clearance K252972 for CARTO 3 EP Navigation System V8.4, Substantially Equivalent on 2026-02-20. Applicant: Biosense Webster, Inc.. Device class: 2.

Summary

Biosense Webster's CARTO 3 EP Navigation System V8.4 is filed under product code DQK (Computer, Diagnostic, Programmable). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).

Biosense Webster filed from Irvine, California. Review took 156 calendar days (September 17, 2025 to February 20, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant
Biosense Webster, Inc.
Product code
Product code DQK
Device class
Class 2
Regulation
21 CFR 870.1425
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DQK

product code DQK
Death
10
Injury
225
Malfunction
2,123
Other
2
Total
2,360

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.