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FDA 510(k)

SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD

K-Number: K052790 · 2005-12-23

ApplicantCardinal Health, Alaris Products
Decision Date2005-12-23
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Alaris Products. It received FDA 510(k) clearance on 2005-12-23 under 510(k) number K052790. 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 SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD?

SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD is a medical device that received FDA 510(k) clearance on 2005-12-23. The listed applicant is Cardinal Health, Alaris Products. The 510(k) number is K052790.

When did SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD receive FDA 510(k) clearance?

SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD received FDA 510(k) clearance on 2005-12-23, under 510(k) number K052790.

Who is the listed applicant for SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD?

The FDA 510(k) record lists Cardinal Health, Alaris Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD?

The FDA product code for SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD is LHI.

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Other records listing Cardinal Health, Alaris Products 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.

K071400SMARTSITE STOPCOCKK071108TEXIUM SYRINGEK061285SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETSK053049ALARIS SAFETY MALE LUERK051641ALARIS SYSTEM PC UNIT, MODEL 8001K050115BLOOD HAND PUMP ADMINISTRATION SET

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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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