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FDA 510(k)

THE I.V. BAG

K-Number: K844664 · 1985-05-06

ApplicantKabivitrum, Inc.
Decision Date1985-05-06
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE I.V. BAG is the device name listed in this FDA 510(k) record. The listed applicant is Kabivitrum, Inc.. It received FDA 510(k) clearance on 1985-05-06 under 510(k) number K844664. 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 THE I.V. BAG?

THE I.V. BAG is a medical device that received FDA 510(k) clearance on 1985-05-06. The listed applicant is Kabivitrum, Inc.. The 510(k) number is K844664.

When did THE I.V. BAG receive FDA 510(k) clearance?

THE I.V. BAG received FDA 510(k) clearance on 1985-05-06, under 510(k) number K844664.

Who is the listed applicant for THE I.V. BAG?

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

What is the FDA product code for THE I.V. BAG?

The FDA product code for THE I.V. BAG is KPE.

Other records listing Kabivitrum, Inc. 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.

K884058COATEST PROTEIN CK854572COATEST PLASMINOGENK833890COATEST ANTIPLASMINK833892COATEST FACTOR VIIIK833891COATEST HEPARINK832114COATEST FACTOR X

View all 8 devices →

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

View on FDA Database →

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

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