510(k) K896907

3M IV FLOW REGULATOR by 3M Company — Product Code LDR

K896907 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M IV FLOW REGULATOR". The FDA issued a decision of Substantially Equivalent on February 26, 1990. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. 3M Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1990
Date Received
December 8, 1989
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