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Medical Devices / Submissions and Approvals

International Biophysics’ Disposable Heart Pump Achieves FDA Clearance

Jan. 24, 2018

The FDA cleared the FloPump 32 centrifugal disposable heart pump manufactured by International Biophysics.

The single use pump is intended for use with the company’s Maquet RotaFlow console.

FloPump 32 is one of the smallest centrifugal pumps in the world at 32ml prime, the company said. The product received a CE Mark in Europe and ANVISA clearance in Brazil last year.

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