CELSITE/ CELSITE CONCEPT, ACCESS PORTS— 510(k) K061424

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K061424 for CELSITE/ CELSITE CONCEPT, ACCESS PORTS, Substantially Equivalent on 2006-07-31. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2006-05-23
Decision date: 2006-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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.