NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET— 510(k) K113471

Substantially Equivalent

Nipro Medical Corporation

FDA 510(k) clearance K113471 for NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET, Substantially Equivalent on 2012-10-18. Applicant: Nipro Medical Corporation.

Clearance details

Applicant: Nipro Medical Corporation
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2011-11-22
Decision date: 2012-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.