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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 a medical device manufactured by International Biophysics Corporation. It received FDA 510(k) clearance on 2021-03-10 under approval 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. It is manufactured by International Biophysics Corporation. The 510(k) number is K193663.

When was FloPump 57mL Centrifugal Pump approved by the FDA?

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

What company makes FloPump 57mL Centrifugal Pump?

FloPump 57mL Centrifugal Pump is manufactured by International Biophysics Corporation.

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

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

Other Devices by International Biophysics Corporation

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

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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