510(k) K080976

NEXUS I.V. FLUID TRANSFER DEVICE by Nexus Medical, LLC — Product Code LHI

K080976 is an FDA 510(k) premarket notification submitted by Nexus Medical, LLC for the device "NEXUS I.V. FLUID TRANSFER DEVICE". The FDA issued a decision of Substantially Equivalent on November 10, 2008. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Nexus Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2008
Date Received
April 7, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type