EVA TPN BAG— 510(k) K101412

Name: FDA 510(k) clearance K101412
Creator: U.S. Food and Drug Administration
Published: 2011-04-13

Substantially Equivalent

Valmed S.R.L.

FDA 510(k) clearance K101412 for EVA TPN BAG, Substantially Equivalent on 2011-04-13. Applicant: Valmed S.R.L.. Device class: 2.

Clearance details

Applicant: Valmed S.R.L.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 2010-05-20
Decision date: 2011-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mazzo Di Valtellina So, IT

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.