www.fdanews.com/articles/202368-becton-dickinsons-hemodialysis-catheter-gets-fda-510k-clearance
Becton Dickinson’s Hemodialysis Catheter Gets FDA 510(k) Clearance
April 16, 2021
The FDA has granted 510(k) clearance to Becton Dickinson’s Pristine Long-Term Hemodialysis Catheter, a device designed to address complications that can cause obstructions and impact performance.
The Pristine catheter has a tip designed to avoid potential complications, including positional occlusion, high recirculation rates and thrombus formation.
The device features a side-hole free tip that minimizes blood-clot adhesion that sometimes occurs when using side-hole catheters and supports blood-clot removal prior to hemodialysis.