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FDA 510(k)

FloPump 57mL Centrifugal Pump

K-Number: K193663 · 2021-03-10

ApplicantInternational Biophysics Corporation
Decision Date2021-03-10
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FloPump 57mL Centrifugal Pump is the device name listed in this FDA 510(k) record. The listed applicant is International Biophysics Corporation. It received FDA 510(k) clearance on 2021-03-10 under 510(k) number K193663. 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 FloPump 57mL Centrifugal Pump?

FloPump 57mL Centrifugal Pump is a medical device that received FDA 510(k) clearance on 2021-03-10. The listed applicant is International Biophysics Corporation. The 510(k) number is K193663.

When did FloPump 57mL Centrifugal Pump receive FDA 510(k) clearance?

FloPump 57mL Centrifugal Pump received FDA 510(k) clearance on 2021-03-10, under 510(k) number K193663.

Who is the listed applicant for FloPump 57mL Centrifugal Pump?

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

What is the FDA product code for FloPump 57mL Centrifugal Pump?

The FDA product code for FloPump 57mL Centrifugal Pump is KFM.

Other records listing International Biophysics 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.

K170029FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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