Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector— 510(k) K150084

Substantially Equivalent

Covidien

FDA 510(k) clearance K150084 for Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector, Substantially Equivalent on 2015-07-13. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2015-01-15
Decision date: 2015-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

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.