Diana ChemoClave Transfer Set— 510(k) K190157

Substantially Equivalent

Icu Medical

FDA 510(k) clearance K190157 for Diana ChemoClave Transfer Set, Substantially Equivalent on 2019-10-23. Applicant: Icu Medical.

Clearance details

Applicant: Icu Medical
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2019-01-30
Decision date: 2019-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ONB

product code ONB

Malfunction: 3,615
Other: 13
Total: 3,628

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.