510(k) K150733

Vital-Port Vascular Access System Power Injectable Port by Cook Incorporated — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2015
Date Received
March 20, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type