510(k) K121094

MEDCOMP VASCU-PICC & MIDLINE CATHETERS by Medical Components, Inc. — Product Code LJS

K121094 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "MEDCOMP VASCU-PICC & MIDLINE CATHETERS". The FDA issued a decision of Substantially Equivalent on June 6, 2012. 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. Medical Components, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2012
Date Received
April 10, 2012
Clearance Type
Special
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