PEH — Hemodialysis Catheter Luer End Cap Class II
FDA product code PEH covers "Hemodialysis Catheter Luer End Cap", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PEH
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
For use in hemodialysis catheters to reduce hub infection.