510(k) K133073

CAIR DRIVE, NEUTRACLEAR by Cair Lgl — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2014
Date Received
September 30, 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