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FDA 510(k)

CDI Blood Parameter Monitoring System 550

K-Number: K182110 · 2018-11-02

ApplicantTerumo Cardiovascular Systems Corporation
Decision Date2018-11-02
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CDI Blood Parameter Monitoring System 550 is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K182110. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CDI Blood Parameter Monitoring System 550?

CDI Blood Parameter Monitoring System 550 is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K182110.

When did CDI Blood Parameter Monitoring System 550 receive FDA 510(k) clearance?

CDI Blood Parameter Monitoring System 550 received FDA 510(k) clearance on 2018-11-02, under 510(k) number K182110.

Who is the listed applicant for CDI Blood Parameter Monitoring System 550?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CDI Blood Parameter Monitoring System 550?

The FDA product code for CDI Blood Parameter Monitoring System 550 is DRY.

Other records listing Terumo Cardiovascular Systems Corporation 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.

K234065CDI OneView Monitoring SystemK221895Terumo Advanced Perfusion System 1K200091Capiox iCP Centrifugal PumpK180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)K172220Advanced Perfusion System 1

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Related Devices (Code: DRY)

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.

K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.K181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd.K163657Quantum WorkstationSpectrum Medical , Ltd.

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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