DeviceClearance

K003315

Substantially Equivalent

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

Applicant
Mallinckrodt, Inc.
Product code
JOH
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
St. Charles, MO, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JOH

product code JOH
Death
42
Injury
1,344
Malfunction
5,608
Other
1
Total
6,995

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.