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FDA 510(k)

Capiox iCP Centrifugal Pump

K-Number: K200091 · 2021-11-18

ApplicantTerumo Cardiovascular Systems Corporation
Decision Date2021-11-18
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Capiox iCP Centrifugal Pump is a medical device manufactured by Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2021-11-18 under approval number K200091. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capiox iCP Centrifugal Pump?

Capiox iCP Centrifugal Pump is a medical device that received FDA 510(k) clearance on 2021-11-18. It is manufactured by Terumo Cardiovascular Systems Corporation. The 510(k) number is K200091.

When was Capiox iCP Centrifugal Pump approved by the FDA?

Capiox iCP Centrifugal Pump received FDA 510(k) clearance on 2021-11-18, under approval number K200091.

What company makes Capiox iCP Centrifugal Pump?

Capiox iCP Centrifugal Pump is manufactured by Terumo Cardiovascular Systems Corporation.

What is the FDA product code for Capiox iCP Centrifugal Pump?

The FDA product code for Capiox iCP Centrifugal Pump is KFM.

Other Devices by Terumo Cardiovascular Systems Corporation

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Related Devices (Code: KFM)

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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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