CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)— 510(k) K120550

Substantially Equivalent

Biosense Webster, Inc.

FDA 510(k) clearance K120550 for CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD), Substantially Equivalent on 2012-05-07. Applicant: Biosense Webster, Inc..

Clearance details

Applicant: Biosense Webster, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2012-02-23
Decision date: 2012-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Diamond Bar, CA, US

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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, 2020-01-01 through 2026-04-23. 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.