DeviceClearance

Product code OMF— General Hospital

LUMENVU CATHETER GUIDANCE SYSTEM

Classification name
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
Device class
Class 2
Regulation
21 CFR 880.5970
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OMF under 21 CFR 880.5970, via openFDA

Market context for product code OMF

FDA has cleared 2 devices under product code OMF between 2009 and 2010, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OMF

Recent clearances under product code OMF

Data sourced from openFDA. This site is unofficial and independent of the FDA.