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510(k) K880006

STA-SET I.V. FLOW REGULATOR by Controlled Flow , Ltd. — Product Code LDR

K880006 is an FDA 510(k) premarket notification submitted by Controlled Flow , Ltd. for the device "STA-SET I.V. FLOW REGULATOR". The FDA issued a decision of Substantially Equivalent on March 24, 1988. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
January 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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FDA data resources