510(k) K041844

ALL SAFE HUBER SAFETY INFUSION SETS by Nexus Medical, LLC — Product Code FPA

K041844 is an FDA 510(k) premarket notification submitted by Nexus Medical, LLC for the device "ALL SAFE HUBER SAFETY INFUSION SETS". The FDA issued a decision of Substantially Equivalent on September 3, 2004. The device falls under product code FPA (Set, Administration, Intravascular), 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
September 3, 2004
Date Received
July 8, 2004
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