BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR— 510(k) K983559

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K983559 for BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR, Substantially Equivalent on 1998-12-24. Applicant: Icu Medical, Inc..

Clearance details

Applicant: Icu Medical, Inc.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 1998-10-13
Decision date: 1998-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

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Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.