ODY — Tunneled Catheter Remover Class II
FDA product code ODY covers "Tunneled Catheter Remover", a Class II medical device regulated under 21 CFR 880.5970. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ODY
- Device Class
- Class II
- Regulation Number
- 880.5970
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.