Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
The Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position (product code OMF) is a Class 2 implantable device regulated under 21 CFR 880.5970 in the General Hospital specialty (HO), cleared via 510(k). When used with a locator instrument, it is designed to aid in the real-time placement of central venous catheters by providing positional information during catheter insertion. The device is flagged as an implant due to its percutaneous, long-term implanted nature, and is not classified as life-sustaining.
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Basic Information
- Product Code
- OMF
- Device Class
- FDA class 2
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.