510(k) K230400

Cure Catheter Closed System; Cure Dextra Closed System by Convatec, Inc. — Product Code EZD

K230400 is an FDA 510(k) premarket notification submitted by Convatec, Inc. for the device "Cure Catheter Closed System; Cure Dextra Closed System". The FDA issued a decision of Substantially Equivalent (kit) on November 8, 2023. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Convatec, Inc. has at least 10 other 510(k) clearances on record.