510(k) K163358— Introcan Safety 3 Closed IV Catheter

Substantially Equivalent

B.Braun Melsungen AG

Clearance details

Applicant: B.Braun Melsungen AG
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2016-11-30
Decision date: 2017-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Melsungen, DE

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.