PEH
- Product code
- PEH
- Device name
- Hemodialysis Catheter Luer End Cap
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5540
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
For use in hemodialysis catheters to reduce hub infection.
Official FDA classification page: PEH
Classification and pathway per current FDA publications. Data from openFDA (CC0).