510(k) K062425

LIFECATH S PICC AND MIDLINE CATHETER by Vygon Corp. — Product Code LJS

K062425 is an FDA 510(k) premarket notification submitted by Vygon Corp. for the device "LIFECATH S PICC AND MIDLINE CATHETER". The FDA issued a decision of Substantially Equivalent on September 15, 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. Vygon Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2006
Date Received
August 18, 2006
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