510(k) K993729— MODIFICATION TO CARTO EP NAVIGATION SYSTEM

Substantially Equivalent

Biosense Webster, Inc.

Clearance details

Applicant: Biosense Webster, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 1999-11-04
Decision date: 1999-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Diamond Bar, CA, US

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.