PRIMARY IV SET— 510(k) K964435

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K964435 for PRIMARY IV SET, Substantially Equivalent on 1997-04-02. Applicant: Icu Medical, Inc..

Clearance details

Applicant: Icu Medical, Inc.
Product code: Code FMG
Advisory panel: General Hospital
Date received: 1996-11-05
Decision date: 1997-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

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Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.