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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 a medical device manufactured by Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2018-11-02 under approval 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. It is manufactured by Terumo Cardiovascular Systems Corporation. The 510(k) number is K182110.

When was CDI Blood Parameter Monitoring System 550 approved by the FDA?

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

What company makes CDI Blood Parameter Monitoring System 550?

CDI Blood Parameter Monitoring System 550 is manufactured by Terumo Cardiovascular Systems Corporation.

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.

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Other Devices by Terumo Cardiovascular Systems Corporation

K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 K160206VirtuoSaph Plus Endoscopic Vessel Harvesting System K172220Advanced Perfusion System 1 K163531Advanced Perfusion System 1 K180950Terumo 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)

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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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