DYE MANAGEMENT SYSTEM— 510(k) K063784

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K063784 for DYE MANAGEMENT SYSTEM, Substantially Equivalent on 2007-04-16. Applicant: Icu Medical, Inc..

Clearance details

Applicant: Icu Medical, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2006-12-21
Decision date: 2007-04-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

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Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.