K022116

Substantially Equivalent

ELPH INJECTION SYSTEM

Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
Product code: DXT
Advisory panel: Cardiovascular
Date received: 2002-07-01
Decision date: 2002-07-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, US

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.