K851856

Substantially Equivalent

TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE

Applicant
Sheridan Catheter Corp.
Product code
CBI
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Argyle, NY, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code CBI

product code CBI
Death
4
Malfunction
594
Total
598

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.