510(k) K171132

Carefusion NeutraClear Needle-free connector by Cair Lgl — Product Code FPA

K171132 is an FDA 510(k) premarket notification submitted by Cair Lgl for the device "Carefusion NeutraClear Needle-free connector". The FDA issued a decision of Substantially Equivalent on July 31, 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
July 31, 2017
Date Received
April 17, 2017
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