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www.fdanews.com/articles/203324-bd-gains-510k-clearance-for-peritx-peritoneal-catheter-system

BD Gains 510(k) Clearance for PeritX Peritoneal Catheter System

June 25, 2021

The FDA has granted Becton Dickinson (BD) 510(k) clearance for the newest version of its PeritX peritoneal catheter system.

BD originally introduced the device in 2005 for treatment of malignant ascites, a debilitating condition that causes the buildup of fluid in the abdomen.

The newly cleared indication has extended the device’s use for draining symptomatic, recurrent nonmalignant ascites and to ease symptoms related to recurrent ascites.

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