510(k) K992424— SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20

Substantially Equivalent

Plastimed Laboratoire Pharmaceutique

Clearance details

Applicant: Plastimed Laboratoire Pharmaceutique
Product code: Code LJS
Advisory panel: General Hospital
Date received: 1999-07-21
Decision date: 2000-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedex, FR

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.