K063503

Substantially Equivalent

OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION

Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
Product code: IZQ
Advisory panel: Cardiovascular
Date received: 2006-11-20
Decision date: 2007-04-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, US

Adverse events under product code IZQ

product code IZQ

Death: 7
Total: 7

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.