KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS— 510(k) K040196

Substantially Equivalent

Tyco Healthcare/Kendall

FDA 510(k) clearance K040196 for KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS, Substantially Equivalent on 2004-05-05. Applicant: Tyco Healthcare/Kendall.

Clearance details

Applicant: Tyco Healthcare/Kendall
Product code: Code LZH
Advisory panel: General Hospital
Date received: 2004-01-29
Decision date: 2004-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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Adverse events under product code LZH

product code LZH

Death: 12
Malfunction: 4,186
Total: 4,198

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.