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FDA 510(k)

ROBERTSITE VIAL ADAPTER, MODEL 245700021

K-Number: K040634 · 2004-03-23

ApplicantHalkey-Roberts Corp.
Decision Date2004-03-23
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ROBERTSITE VIAL ADAPTER, MODEL 245700021 is the device name listed in this FDA 510(k) record. The listed applicant is Halkey-Roberts Corp.. It received FDA 510(k) clearance on 2004-03-23 under 510(k) number K040634. 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 ROBERTSITE VIAL ADAPTER, MODEL 245700021?

ROBERTSITE VIAL ADAPTER, MODEL 245700021 is a medical device that received FDA 510(k) clearance on 2004-03-23. The listed applicant is Halkey-Roberts Corp.. The 510(k) number is K040634.

When did ROBERTSITE VIAL ADAPTER, MODEL 245700021 receive FDA 510(k) clearance?

ROBERTSITE VIAL ADAPTER, MODEL 245700021 received FDA 510(k) clearance on 2004-03-23, under 510(k) number K040634.

Who is the listed applicant for ROBERTSITE VIAL ADAPTER, MODEL 245700021?

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

What is the FDA product code for ROBERTSITE VIAL ADAPTER, MODEL 245700021?

The FDA product code for ROBERTSITE VIAL ADAPTER, MODEL 245700021 is LHI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Halkey-Roberts Corp. 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.

K061143ROBERTSITE STOPCOCK

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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