510(k) Report

Devices descending from K981125

9 later devices reach Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123292T3Medcomp20132—
+1K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.20123—
+1K111651Split Cath IiiMedical Components, Inc.201101
+1K090528Duet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis Catheter System…C.R. Bard, Inc.20090—
+2K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+2K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+2K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+3K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+3K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—