NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE— 510(k) K053194

Substantially Equivalent

Biosense Webster, Inc.

FDA 510(k) clearance K053194 for NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE, Substantially Equivalent on 2006-03-09. Applicant: Biosense Webster, Inc..

Clearance details

Applicant: Biosense Webster, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2005-11-15
Decision date: 2006-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palos Verdes Estates, CA, US

Download summary PDF View on FDA.gov ↗

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.