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FDA 510(k)

EVA TPN BAG

K-Number: K101412 · 2011-04-13

ApplicantValmed S.R.L.
Decision Date2011-04-13
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EVA TPN BAG is the device name listed in this FDA 510(k) record. The listed applicant is Valmed S.R.L.. It received FDA 510(k) clearance on 2011-04-13 under 510(k) number K101412. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVA TPN BAG?

EVA TPN BAG is a medical device that received FDA 510(k) clearance on 2011-04-13. The listed applicant is Valmed S.R.L.. The 510(k) number is K101412.

When did EVA TPN BAG receive FDA 510(k) clearance?

EVA TPN BAG received FDA 510(k) clearance on 2011-04-13, under 510(k) number K101412.

Who is the listed applicant for EVA TPN BAG?

The FDA 510(k) record lists Valmed S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVA TPN BAG?

The FDA product code for EVA TPN BAG is KPE.

Other records listing Valmed S.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181393Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP

Related Devices (Code: KPE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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