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FDA 510(k)

VIALOK SINGLE VIAL ACCESS DEVICE VENTED

K-Number: K122265 · 2012-08-14

ApplicantYukon Medical, LLC
Decision Date2012-08-14
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VIALOK SINGLE VIAL ACCESS DEVICE VENTED is the device name listed in this FDA 510(k) record. The listed applicant is Yukon Medical, LLC. It received FDA 510(k) clearance on 2012-08-14 under 510(k) number K122265. 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 VIALOK SINGLE VIAL ACCESS DEVICE VENTED?

VIALOK SINGLE VIAL ACCESS DEVICE VENTED is a medical device that received FDA 510(k) clearance on 2012-08-14. The listed applicant is Yukon Medical, LLC. The 510(k) number is K122265.

When did VIALOK SINGLE VIAL ACCESS DEVICE VENTED receive FDA 510(k) clearance?

VIALOK SINGLE VIAL ACCESS DEVICE VENTED received FDA 510(k) clearance on 2012-08-14, under 510(k) number K122265.

Who is the listed applicant for VIALOK SINGLE VIAL ACCESS DEVICE VENTED?

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

What is the FDA product code for VIALOK SINGLE VIAL ACCESS DEVICE VENTED?

The FDA product code for VIALOK SINGLE VIAL ACCESS DEVICE VENTED is LHI.

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Other records listing Yukon Medical, LLC 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.

K240761Arisure® Closed Male Luer with Spike Adapter (YM060)K243486SmartSiteTM Vented Vial Access DeviceK201422Arisure Closed System Drug Transfer Device (CSTD)K132863SMARTSITE VIALSHIELDK121182VIALOK NON-VENTEDK120799ARISURE NEUTRAL VALVE

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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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