OMF — Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position Class II
FDA product code OMF covers "Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position", a Class II medical device regulated under 21 CFR 880.5970. Submissions are reviewed by the General Hospital panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
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.