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FDA 510(k)

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

K-Number: K170029 · 2017-12-15

ApplicantInternational Biophysics Corporation
Decision Date2017-12-15
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile is a medical device manufactured by International Biophysics Corporation. It received FDA 510(k) clearance on 2017-12-15 under approval number K170029. 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 32mL, Sterile, FloPump 32mL, Non-Sterile?

FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile is a medical device that received FDA 510(k) clearance on 2017-12-15. It is manufactured by International Biophysics Corporation. The 510(k) number is K170029.

When was FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile approved by the FDA?

FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile received FDA 510(k) clearance on 2017-12-15, under approval number K170029.

What company makes FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile?

FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile is manufactured by International Biophysics Corporation.

What is the FDA product code for FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile?

The FDA product code for FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile is KFM.

Other Devices by International Biophysics Corporation

K193663FloPump 57mL Centrifugal Pump

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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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