510(k) Report

Devices descending from K002901

19 later devices reach Kendall 14.5 FR Maxid Cuffed Dual Lumen Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111372Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual…Covidien201110Class I
+1K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM…Ash Access Technology, Inc.200773
+2K182443Pristine Hemodialysis CatheterPristine Access Technologies, Ltd.20192—
+2K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien20134Class I
+2K112477Palindrome H, SI, Hsi Chronic CatheterCovidien20115Class I
+2K111817Palindrome RT Chronic CatheterCovidien2011013
+2K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc.20092—
+2K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.200865
+3K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.20211—
+3K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical20143—
+3K141363Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis CatheterMerit Medical Systems, Inc.20141—
+3K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.20102Class I
+4K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+4K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.)20172—
+4K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc.20160Class I
+4K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+4K110936Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.201106
+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—