Class Class II

lntravascular Administration Sets with Stopcock and Manifold (K223175)

K223175 2023-03-10 Traditional
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Description

lntravascular Administration Sets with Stopcock and Manifold by Baxter Healthcare Corporation, an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK223175
Clearance Date2023-03-10
Clearance TypeTraditional
Product CodeFMG
Regulation Number880.5440

Categories

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Predicate lineage for K223175

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. lntravascular Administration Sets with Stopcock and Manifold (K223175) 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
K130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE...Baxter Healthcare Corp2013

Trace the full predicate network for K223175

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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