FDA 510(k)

BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device

K-Number: K222478 · 2023-03-10

Decision Date2023-03-10

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-03-10 under 510(k) number K222478. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device?

BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device is a medical device that received FDA 510(k) clearance on 2023-03-10. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K222478.

When did BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device receive FDA 510(k) clearance?

BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device received FDA 510(k) clearance on 2023-03-10, under 510(k) number K222478.

Who is the listed applicant for BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device?

The FDA product code for BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device is JKA.

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Other records listing Becton, Dickinson and Company as applicant

PMA P160037KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS K260128BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube K260184Onclarity™ Self-Collection Kit K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

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Related Devices (Code: JKA)

K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company K251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

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.