CELSITE VENOUS ACCESS SYSTEM OTW— 510(k) K954297

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K954297 for CELSITE VENOUS ACCESS SYSTEM OTW, Substantially Equivalent on 1995-12-01. Applicant: B.Braun Medical, Inc..

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1995-09-14
Decision date: 1995-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, 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.