Diana Medication Transfer Set— 510(k) K170110

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K170110 for Diana Medication Transfer Set, Substantially Equivalent on 2018-08-10. Applicant: Icu Medical, Inc..

Clearance details

Applicant: Icu Medical, Inc.
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2017-01-12
Decision date: 2018-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, 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.