510(k) K130923

5F DIGNITY CT TITANIUM PORT by Medical Components, Inc. — Product Code LJT

K130923 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "5F DIGNITY CT TITANIUM PORT". The FDA issued a decision of Substantially Equivalent on July 31, 2013. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Medical Components, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2013
Date Received
April 3, 2013
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