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FDA 510(k)

LifeFlow Blood System

K-Number: K191362 · 2020-05-20

Applicant410 Medical, Inc.
Decision Date2020-05-20
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LifeFlow Blood System is the device name listed in this FDA 510(k) record. The listed applicant is 410 Medical, Inc.. It received FDA 510(k) clearance on 2020-05-20 under 510(k) number K191362. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeFlow Blood System?

LifeFlow Blood System is a medical device that received FDA 510(k) clearance on 2020-05-20. The listed applicant is 410 Medical, Inc.. The 510(k) number is K191362.

When did LifeFlow Blood System receive FDA 510(k) clearance?

LifeFlow Blood System received FDA 510(k) clearance on 2020-05-20, under 510(k) number K191362.

Who is the listed applicant for LifeFlow Blood System?

The FDA 510(k) record lists 410 Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LifeFlow Blood System?

The FDA product code for LifeFlow Blood System is FPA.

Related Devices (Code: FPA)

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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.

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