DeviceClearance

K151315

Substantially Equivalent

Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle

Applicant
Boston Scientific Corporation
Product code
EOQ
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marlboro, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ
Death
135
Injury
2,863
Malfunction
21,662
Total
24,660

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.