510(k) K092930

NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED by Nexus Medical, LLC — Product Code FPA

K092930 is an FDA 510(k) premarket notification submitted by Nexus Medical, LLC for the device "NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED". The FDA issued a decision of Substantially Equivalent on March 10, 2010. 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
March 10, 2010
Date Received
September 22, 2009
Clearance Type
Special
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