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FDA 510(k)

Fluido Compact Blood and Fluid Warming System

K-Number: K211618 · 2023-06-05

ApplicantThe Surgical Company International B.V.
Decision Date2023-06-05
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Fluido Compact Blood and Fluid Warming System is a medical device manufactured by The Surgical Company International B.V.. It received FDA 510(k) clearance on 2023-06-05 under approval number K211618. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fluido Compact Blood and Fluid Warming System?

Fluido Compact Blood and Fluid Warming System is a medical device that received FDA 510(k) clearance on 2023-06-05. It is manufactured by The Surgical Company International B.V.. The 510(k) number is K211618.

When was Fluido Compact Blood and Fluid Warming System approved by the FDA?

Fluido Compact Blood and Fluid Warming System received FDA 510(k) clearance on 2023-06-05, under approval number K211618.

What company makes Fluido Compact Blood and Fluid Warming System?

Fluido Compact Blood and Fluid Warming System is manufactured by The Surgical Company International B.V..

What is the FDA product code for Fluido Compact Blood and Fluid Warming System?

The FDA product code for Fluido Compact Blood and Fluid Warming System is LGZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by The Surgical Company International B.V.

K252636Fluido Compact System

Related Devices (Code: LGZ)

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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.

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