K912944

Substantially Equivalent

CT 8000 DIGITAL INJECTION SYSTEM

Applicant: Mallinckrodt Group, Inc.
Product code: DXT
Advisory panel: Cardiovascular
Date received: 1991-07-05
Decision date: 1992-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
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.