510(k) K102966

2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC by Medcomp — Product Code LJS

K102966 is an FDA 510(k) premarket notification submitted by Medcomp for the device "2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC". The FDA issued a decision of Substantially Equivalent on December 21, 2010. 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 has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2010
Date Received
October 5, 2010
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