510(k) K130576

CELSITE IMPLANTABLE ACCESS PORT SYSTEMS by B. Braun Interventional Systems, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2013
Date Received
March 5, 2013
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