K921755

Substantially Equivalent

8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS

Applicant: Davol, Inc.
Product code: LJS
Advisory panel: General Hospital
Date received: 1992-04-13
Decision date: 1992-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.