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510(k) K191362

LifeFlow Blood System by 410 Medical, Inc. — Product Code FPA

K191362 is an FDA 510(k) premarket notification submitted by 410 Medical, Inc. for the device "LifeFlow Blood System". The FDA issued a decision of Substantially Equivalent on May 20, 2020. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2020
Date Received
May 22, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type
510(k)

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FDA data resources