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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 the device name listed in this FDA 510(k) record. The listed applicant is The Surgical Company International B.V.. It received FDA 510(k) clearance on 2023-06-05 under 510(k) 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. The listed applicant is The Surgical Company International B.V.. The 510(k) number is K211618.

When did Fluido Compact Blood and Fluid Warming System receive FDA 510(k) clearance?

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

Who is the listed applicant for Fluido Compact Blood and Fluid Warming System?

The FDA 510(k) record lists The Surgical Company International B.V. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing The Surgical Company International B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252636Fluido Compact System

Related Devices (Code: LGZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260988°M Warmer System with °M StationMequ A/SK252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/SK211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid WarmerQuality IN Flow , Ltd.K202461ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemSmisson-Cartledge Biomedical, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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