EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE— 510(k) K012879

Substantially Equivalent

Exelint Intl. Co.

FDA 510(k) clearance K012879 for EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE, Substantially Equivalent on 2002-01-17. Applicant: Exelint Intl. Co..

Clearance details

Applicant: Exelint Intl. Co.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2001-08-28
Decision date: 2002-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.