OPTISTAR MR INJECTOR SYSTEM— 510(k) K984088

Substantially Equivalent

Mallinckrodt Inc., Liebel-Flarsheim Business

FDA 510(k) clearance K984088 for OPTISTAR MR INJECTOR SYSTEM, Substantially Equivalent on 1999-12-06. Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business.

Clearance details

Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1998-11-16
Decision date: 1999-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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.