Class Class II

BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device (K222478)

K222478 2023-03-10 Traditional
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Description

BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device by Becton, Dickinson and Company, an FDA 510(k) cleared clinical chemistry device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222478
Clearance Date2023-03-10
Clearance TypeTraditional
Product CodeJKA
Regulation Number862.1675

Categories

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Predicate lineage for K222478

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device (K222478) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K200027Blood Collection Needle with/without Holder, Safety Blood C...Jiangsu Caina Medical Co.,Ltd2020

Trace the full predicate network for K222478

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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