510(k) Report

Devices descending from K113487

3 later devices reach Hemo-Cath 10F, Hemo-Cath 12.5F through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+1K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+2K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—