LIFEGUARD SAFETY INFUSION SET— 510(k) K013871

Substantially Equivalent

Horizon Medical Products, Inc.

FDA 510(k) clearance K013871 for LIFEGUARD SAFETY INFUSION SET, Substantially Equivalent on 2002-03-29. Applicant: Horizon Medical Products, Inc..

Clearance details

Applicant: Horizon Medical Products, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2001-11-21
Decision date: 2002-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, GA, US

Download summary PDF View on FDA.gov ↗

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.