510(k) K213602

Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit by Covidien, LLC — Product Code FJS

K213602 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit". The FDA issued a decision of Substantially Equivalent on January 14, 2022. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Covidien, LLC has at least 10 other 510(k) clearances on record.