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FDA 510(k)

MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW

K-Number: K972117 · 1997-08-26

ApplicantMedical Specialty Innovations, Inc. (Msi)
Decision Date1997-08-26
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialty Innovations, Inc. (Msi). It received FDA 510(k) clearance on 1997-08-26 under 510(k) number K972117. 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 MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW?

MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW is a medical device that received FDA 510(k) clearance on 1997-08-26. The listed applicant is Medical Specialty Innovations, Inc. (Msi). The 510(k) number is K972117.

When did MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW receive FDA 510(k) clearance?

MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW received FDA 510(k) clearance on 1997-08-26, under 510(k) number K972117.

Who is the listed applicant for MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW?

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

What is the FDA product code for MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW?

The FDA product code for MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW is LHI.

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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.

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Other records listing Medical Specialty Innovations, Inc. (Msi) 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.

K974672MSI SURGICAL DRAPES

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

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

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