COMPAT ENTERAL DELIVERY PUMP SETS— 510(k) K140947

Name: FDA 510(k) clearance K140947
Creator: U.S. Food and Drug Administration
Published: 2014-09-04

Substantially Equivalent

Nestle Healthcare Nutrition, Inc.

FDA 510(k) clearance K140947 for COMPAT ENTERAL DELIVERY PUMP SETS, Substantially Equivalent on 2014-09-04. Applicant: Nestle Healthcare Nutrition, Inc.. Device class: 2.

Clearance details

Applicant: Nestle Healthcare Nutrition, Inc.
Product code: Code PIF
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2014-04-14
Decision date: 2014-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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.