510(k) K140169

VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM by Cook Incorporated — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2014
Date Received
January 23, 2014
Clearance Type
Traditional
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