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FDA 510(k)

BAXJECT II

K-Number: K042410 · 2004-10-08

ApplicantBaxter Healthcare Corp
Decision Date2004-10-08
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BAXJECT II 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 2004-10-08 under 510(k) number K042410. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAXJECT II?

BAXJECT II is a medical device that received FDA 510(k) clearance on 2004-10-08. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K042410.

When did BAXJECT II receive FDA 510(k) clearance?

BAXJECT II received FDA 510(k) clearance on 2004-10-08, under 510(k) number K042410.

Who is the listed applicant for BAXJECT II?

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 BAXJECT II?

The FDA product code for BAXJECT II is LHI.

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Related Devices (Code: LHI)

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K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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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