OMF — Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position Class II

FDA Device Classification

Classification Details

Product Code
OMF
Device Class
Class II
Regulation Number
880.5970
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
Yes

Definition

When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K093510sonositeLUMENVU CATHETER GUIDANCE SYSTEMAugust 23, 2010
K083121corpak medsystemsNEO MAPCATH SENSOR STYLETFebruary 11, 2009