CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB— 510(k) K083786

Name: FDA 510(k) clearance K083786
Creator: U.S. Food and Drug Administration
Published: 2009-02-20

Substantially Equivalent

Corpak Medsystems

FDA 510(k) clearance K083786 for CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB, Substantially Equivalent on 2009-02-20. Applicant: Corpak Medsystems. Device class: 2.

Clearance details

Applicant: Corpak Medsystems
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2008-12-19
Decision date: 2009-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheeling, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.