CARTO ENT System— 510(k) K161701
Substantially EquivalentBiosense Webster
FDA 510(k) clearance K161701 for CARTO ENT System, Substantially Equivalent on 2016-10-24. Applicant: Biosense Webster.
Clearance details
- Applicant
- Biosense Webster
- Product code
- Code PGW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Diamond Bar, CA, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.