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FDA 510(k)

BAG DECANTER

K-Number: K972134 · 1997-08-26

ApplicantRemington Medical, Inc.
Decision Date1997-08-26
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BAG DECANTER is the device name listed in this FDA 510(k) record. The listed applicant is Remington Medical, Inc.. It received FDA 510(k) clearance on 1997-08-26 under 510(k) number K972134. 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 BAG DECANTER?

BAG DECANTER is a medical device that received FDA 510(k) clearance on 1997-08-26. The listed applicant is Remington Medical, Inc.. The 510(k) number is K972134.

When did BAG DECANTER receive FDA 510(k) clearance?

BAG DECANTER received FDA 510(k) clearance on 1997-08-26, under 510(k) number K972134.

Who is the listed applicant for BAG DECANTER?

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

What is the FDA product code for BAG DECANTER?

The FDA product code for BAG DECANTER 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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