510(k) K051690

VYGON NUTRILINE CATHETERS by Vygon Corp. — Product Code LJS

K051690 is an FDA 510(k) premarket notification submitted by Vygon Corp. for the device "VYGON NUTRILINE CATHETERS". The FDA issued a decision of Substantially Equivalent on August 19, 2005. 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
August 19, 2005
Date Received
June 23, 2005
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