TruDi Navigation System— 510(k) K192397

Substantially Equivalent

Biosense Webster

FDA 510(k) clearance K192397 for TruDi Navigation System, Substantially Equivalent on 2020-01-30. Applicant: Biosense Webster.

Clearance details

Applicant: Biosense Webster
Product code: Code PGW
Advisory panel: Neurology
Date received: 2019-09-03
Decision date: 2020-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvin, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PGW

product code PGW

Malfunction: 1,199
Total: 1,199

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.