510(k) K101412

EVA TPN BAG by Valmed S.R.L. — Product Code KPE

K101412 is an FDA 510(k) premarket notification submitted by Valmed S.R.L. for the device "EVA TPN BAG". The FDA issued a decision of Substantially Equivalent on April 13, 2011. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Valmed S.R.L. has at least 7 other 510(k) clearances on record.