FDA 510(k)

VITALMIX PLUS EMPTY I.V. CONTAINER

K-Number: K972464 · 1997-11-05

Decision Date1997-11-05

Product CodeKPE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VITALMIX PLUS EMPTY I.V. CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Device, Inc.. It received FDA 510(k) clearance on 1997-11-05 under 510(k) number K972464. 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 VITALMIX PLUS EMPTY I.V. CONTAINER?

VITALMIX PLUS EMPTY I.V. CONTAINER is a medical device that received FDA 510(k) clearance on 1997-11-05. The listed applicant is Pacific Device, Inc.. The 510(k) number is K972464.

When did VITALMIX PLUS EMPTY I.V. CONTAINER receive FDA 510(k) clearance?

VITALMIX PLUS EMPTY I.V. CONTAINER received FDA 510(k) clearance on 1997-11-05, under 510(k) number K972464.

Who is the listed applicant for VITALMIX PLUS EMPTY I.V. CONTAINER?

The FDA 510(k) record lists Pacific Device, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITALMIX PLUS EMPTY I.V. CONTAINER?

The FDA product code for VITALMIX PLUS EMPTY I.V. CONTAINER is KPE.

Related Clinical Trials

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.

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Other records listing Pacific Device, Inc. as applicant

K923782TRANSFER SET K912860INTRAVASCULAR ADMINISTRATION SETS K912596MECONIUM ASPIRATION K902482VITALMIX (SET & BAG)

Related Devices (Code: KPE)

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG K252094eZSURE™ 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.