510(k) K171118

Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) by Cair Lgl — Product Code FPA

K171118 is an FDA 510(k) premarket notification submitted by Cair Lgl for the device "Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)". The FDA issued a decision of Substantially Equivalent on August 15, 2017. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Cair Lgl has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2017
Date Received
April 14, 2017
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