510(k) Report

Devices descending from K012365

7 later devices reach Vaxcel Dialysis Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K07142215.5F Hemo-Stream Hemodialysis Catheter SetRex Medical20075—
+1K023847Hemo-Stream Hemodialysis Catheter SetRex Medical200363
+2K102043Ultrastream Chronic Hemodialysis CatheterRex Medical201043
+3K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical20143—
+4K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.)20172—
+5K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp)20200—
+5K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…Medical Components, Inc. (dba MedComp)20181—