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FDA 510(k)

Revolution Centrifugal Blood Pump

K-Number: K190650 · 2019-08-07

ApplicantSorin Group Italia S.R.L.
Decision Date2019-08-07
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Revolution Centrifugal Blood Pump is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2019-08-07 under approval number K190650. 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 Revolution Centrifugal Blood Pump?

Revolution Centrifugal Blood Pump is a medical device that received FDA 510(k) clearance on 2019-08-07. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K190650.

When was Revolution Centrifugal Blood Pump approved by the FDA?

Revolution Centrifugal Blood Pump received FDA 510(k) clearance on 2019-08-07, under approval number K190650.

What company makes Revolution Centrifugal Blood Pump?

Revolution Centrifugal Blood Pump is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for Revolution Centrifugal Blood Pump?

The FDA product code for Revolution Centrifugal Blood Pump is KFM.

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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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