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FDA 510(k)

INTRAVIA CONTAINER, EMPTY

K-Number: K964853 · 1997-03-31

ApplicantBaxter Healthcare Corp
Decision Date1997-03-31
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INTRAVIA CONTAINER, EMPTY is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1997-03-31 under 510(k) number K964853. 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 INTRAVIA CONTAINER, EMPTY?

INTRAVIA CONTAINER, EMPTY is a medical device that received FDA 510(k) clearance on 1997-03-31. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K964853.

When did INTRAVIA CONTAINER, EMPTY receive FDA 510(k) clearance?

INTRAVIA CONTAINER, EMPTY received FDA 510(k) clearance on 1997-03-31, under 510(k) number K964853.

Who is the listed applicant for INTRAVIA CONTAINER, EMPTY?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRAVIA CONTAINER, EMPTY?

The FDA product code for INTRAVIA CONTAINER, EMPTY is KPE.

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Other records listing Baxter Healthcare Corp as applicant

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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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