510(k) K061986

1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50 by Medcomp — Product Code LJS

K061986 is an FDA 510(k) premarket notification submitted by Medcomp for the device "1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50". The FDA issued a decision of Substantially Equivalent on August 3, 2006. 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
August 3, 2006
Date Received
July 13, 2006
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