EXEL I.V. BLOOD LINE SET— 510(k) K992039

Substantially Equivalent

Exelint Intl. Co.

FDA 510(k) clearance K992039 for EXEL I.V. BLOOD LINE SET, Substantially Equivalent on 2000-02-10. Applicant: Exelint Intl. Co..

Clearance details

Applicant: Exelint Intl. Co.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 1999-06-17
Decision date: 2000-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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.