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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 the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2019-08-07 under 510(k) 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. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K190650.

When did Revolution Centrifugal Blood Pump receive FDA 510(k) clearance?

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

Who is the listed applicant for Revolution Centrifugal Blood Pump?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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)

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.

K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)Spectrum Medical S.R.L.K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)Qura S.R.LK232132LifeSPARC SystemCardiacassist, Inc.K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsQura S.R.LK200091Capiox iCP Centrifugal PumpTerumo Cardiovascular Systems Corporation

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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