K853830

Substantially Equivalent

SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST

Applicant: Travenol Laboratories, S.A.
Product code: LHI
Advisory panel: General Hospital
Date received: 1985-09-13
Decision date: 1985-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.