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FDA 510(k)

Actifuse Flow

K-Number: K181306 · 2018-08-17

ApplicantBaxter Healthcare Corporation
Decision Date2018-08-17
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Actifuse Flow is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2018-08-17 under 510(k) number K181306. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Actifuse Flow?

Actifuse Flow is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K181306.

When did Actifuse Flow receive FDA 510(k) clearance?

Actifuse Flow received FDA 510(k) clearance on 2018-08-17, under 510(k) number K181306.

Who is the listed applicant for Actifuse Flow?

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

What is the FDA product code for Actifuse Flow?

The FDA product code for Actifuse Flow is MQV.

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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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