510(k) K132177

MEDCOMP GEN III POWER INJECTABLE PORT by Medcomp ( Medical Components) — Product Code LJT

K132177 is an FDA 510(k) premarket notification submitted by Medcomp ( Medical Components) for the device "MEDCOMP GEN III POWER INJECTABLE PORT". The FDA issued a decision of Substantially Equivalent on December 12, 2013. 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
December 12, 2013
Date Received
July 15, 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