Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device

K-Number: K233021 · 2024-03-06

ApplicantCare Fusion
Decision Date2024-03-06
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K233021. 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 BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device?

BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Care Fusion. The 510(k) number is K233021.

When did BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device receive FDA 510(k) clearance?

BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device received FDA 510(k) clearance on 2024-03-06, under 510(k) number K233021.

Who is the listed applicant for BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device?

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

What is the FDA product code for BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device?

The FDA product code for BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device is LHI.

Other records listing Care Fusion 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.

K231888BD Texium™ Needle-Free SyringeK221327BD Alaris™ Pump Infusion SetsK221319BD Alaris™ Pump Epidural Infusion SetK223101BD Secondary Infusion SetK223088BD SmartSite™ Needle-Free ConnectorK223076BD Texium™ Closed Male Luer

View all 14 devices →

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.

↑