510(k) K130897

MEDCOMP VASCU-PICC WITH VALVE by Medcomp ( Medical Components) — Product Code LJS

K130897 is an FDA 510(k) premarket notification submitted by Medcomp ( Medical Components) for the device "MEDCOMP VASCU-PICC WITH VALVE". The FDA issued a decision of Substantially Equivalent on October 22, 2013. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Medcomp ( Medical Components) has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2013
Date Received
April 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type