TruDi Navigation System— 510(k) K192397
Substantially EquivalentBiosense Webster
FDA 510(k) clearance K192397 for TruDi Navigation System, Substantially Equivalent on 2020-01-30. Applicant: Biosense Webster. Device class: 2.
Clearance details
- Applicant
- Biosense Webster
- Product code
- Code PGW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, US
Recent devices under product code PGW
view allMore clearances from Biosense Webster
view allAdverse events under product code PGW
product code PGW- Malfunction
- 1,199
- Total
- 1,199
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K192397
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192397.
Data sourced from openFDA. This site is unofficial and independent of the FDA.