CELSITE, MODELS ST401L, ST405L— 510(k) K994111

Substantially Equivalent

B. Braun/Mcgaw

FDA 510(k) clearance K994111 for CELSITE, MODELS ST401L, ST405L, Substantially Equivalent on 2000-01-03. Applicant: B. Braun/Mcgaw.

Clearance details

Applicant: B. Braun/Mcgaw
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1999-12-06
Decision date: 2000-01-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Allentown, PA, US

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Adverse events under product code LJT

product code LJT

Death: 234
Injury: 6,468
Malfunction: 5,326
Other: 2
Total: 12,030

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.