OMF

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position

Device class

Class II (moderate risk)

Regulation

21 CFR 880.5970

Medical specialty

General Hospital

Flags

Implant

FDA 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.

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