CTLOGICS NAVIGATIONS SYSTEMS— 510(k) K063408

Substantially Equivalent

Praxim Medivision, SA

FDA 510(k) clearance K063408 for CTLOGICS NAVIGATIONS SYSTEMS, Substantially Equivalent on 2007-02-28. Applicant: Praxim Medivision, SA.

Clearance details

Applicant: Praxim Medivision, SA
Product code: Code HAW
Advisory panel: Neurology
Date received: 2006-11-13
Decision date: 2007-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Tronche, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.