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FDA 510(k)

IV DECANTER-FLEXIBLE

K-Number: K980587 · 1998-04-17

ApplicantInrad
Decision Date1998-04-17
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IV DECANTER-FLEXIBLE is the device name listed in this FDA 510(k) record. The listed applicant is Inrad. It received FDA 510(k) clearance on 1998-04-17 under 510(k) number K980587. 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 IV DECANTER-FLEXIBLE?

IV DECANTER-FLEXIBLE is a medical device that received FDA 510(k) clearance on 1998-04-17. The listed applicant is Inrad. The 510(k) number is K980587.

When did IV DECANTER-FLEXIBLE receive FDA 510(k) clearance?

IV DECANTER-FLEXIBLE received FDA 510(k) clearance on 1998-04-17, under 510(k) number K980587.

Who is the listed applicant for IV DECANTER-FLEXIBLE?

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

What is the FDA product code for IV DECANTER-FLEXIBLE?

The FDA product code for IV DECANTER-FLEXIBLE is LHI.

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Other records listing Inrad 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.

K093399PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520K093256SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018K090611REVOLUTION FULL CORE BIOPSYK063238ULTRACLIP II WING AND ULTRACLIP II COILK042341ULTRACLIP II USK041201ULTRACLIP II MR

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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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