OMF · Class II · 21 CFR 880.5970

FDA Product Code OMF: Percutaneous, Implanted, Long-term Intravascular Catheter Accessory For Catheter Position

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.

Leading manufacturers include Corpak Medsystems and Sonosite,Inc..

2
Total
2
Cleared
198d
Avg days
2009
Since

FDA 510(k) Cleared Percutaneous, Implanted, Long-term Intravascular Catheter Accessory For Catheter Position Devices (Product Code OMF)

2 devices
1–2 of 2
Cleared Aug 23, 2010
LUMENVU CATHETER GUIDANCE SYSTEM
K093510
Sonosite,Inc.
General Hospital · 284d
Cleared Feb 11, 2009
NEO MAPCATH SENSOR STYLET
K083121
Corpak Medsystems
General Hospital · 112d

About Product Code OMF - Regulatory Context