510(k) K153238

Dignity Dual Port by Medcomp ( Medical Components) — Product Code LJT

K153238 is an FDA 510(k) premarket notification submitted by Medcomp ( Medical Components) for the device "Dignity Dual Port". The FDA issued a decision of Substantially Equivalent on March 15, 2016. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Medcomp ( Medical Components) has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2016
Date Received
November 9, 2015
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