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 the device name listed in this FDA 510(k) record. The listed applicant is International Biophysics Corporation. It received FDA 510(k) clearance on 2017-12-15 under 510(k) 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. The listed applicant is International Biophysics Corporation. The 510(k) number is K170029.

When did FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile receive FDA 510(k) clearance?

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

Who is the listed applicant for FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile?

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

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

K193663FloPump 57mL Centrifugal Pump

Related Devices (Code: KFM)

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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.