PKI — Fully Subcutaneous Implanted Hemodialysis Catheter Class II
FDA product code PKI covers "Fully Subcutaneous Implanted Hemodialysis Catheter", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants.
Classification Details
- Product Code
- PKI
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
Provides access to the blood for hemodialysis or other chronic uses.