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FDA 510(k)

VIAL-MATE RECONSTITUTION DEVICE (2B8071)

K-Number: K973654 · 1997-10-24

ApplicantBaxter Healthcare Corp
Decision Date1997-10-24
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VIAL-MATE RECONSTITUTION DEVICE (2B8071) 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 1997-10-24 under 510(k) number K973654. 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 VIAL-MATE RECONSTITUTION DEVICE (2B8071)?

VIAL-MATE RECONSTITUTION DEVICE (2B8071) is a medical device that received FDA 510(k) clearance on 1997-10-24. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K973654.

When did VIAL-MATE RECONSTITUTION DEVICE (2B8071) receive FDA 510(k) clearance?

VIAL-MATE RECONSTITUTION DEVICE (2B8071) received FDA 510(k) clearance on 1997-10-24, under 510(k) number K973654.

Who is the listed applicant for VIAL-MATE RECONSTITUTION DEVICE (2B8071)?

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 VIAL-MATE RECONSTITUTION DEVICE (2B8071)?

The FDA product code for VIAL-MATE RECONSTITUTION DEVICE (2B8071) is LHI.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: LHI)

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.

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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