Class Class II

Fluido Compact Blood and Fluid Warming System (K211618)

K211618 2023-06-05 Traditional
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Description

Fluido Compact Blood and Fluid Warming System by The Surgical Company International B.V., an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK211618
Clearance Date2023-06-05
Clearance TypeTraditional
Product CodeLGZ
Regulation Number880.5725

Categories

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Predicate lineage for K211618

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. Fluido Compact Blood and Fluid Warming System (K211618) 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
K112902ENFLOW IV FLUID WARMERVital Signs, Inc.2012

Trace the full predicate network for K211618

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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