510(k) K133351

NEXUS NIS-6P LUER ACTIVATED DEVICE by Nexus Medical, LLC — Product Code FPA

K133351 is an FDA 510(k) premarket notification submitted by Nexus Medical, LLC for the device "NEXUS NIS-6P LUER ACTIVATED DEVICE". The FDA issued a decision of Substantially Equivalent on May 22, 2014. 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
May 22, 2014
Date Received
October 31, 2013
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