510(k) Report

Devices descending from K991320

16 later devices reach Medcomp Duo-Flow II Catheter with Lubricious Heparin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100451Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin…Gambro Renal Products, Inc.20100—
+1K060509Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin CoatingTyco Healthcare Group200674
+1K023914Coaxia Flocontrol CatheterCoaxia, Inc.20036—
+2K112477Palindrome H, SI, Hsi Chronic CatheterCovidien20115Class I
+2K090970Flocontrol , Model 1028Coaxia, Inc.20091—
+2K080700Duoflo CatheterThermopeutix, Inc.20083—
+2K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…Kendall2006624
+3K192786Gatekeeper Balloon CatheterArch Catheter, LLC20200—
+3K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien20134Class I
+3K112219Tapas CatheterThermopeutix, Inc.20111—
+3K093847Duflo Catheter (Heparin Coated)Thermopeutix, Inc.20100—
+4K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical20143—
+4K141175Renovocath RC120Renovorx, Inc.201401
+5K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.)20172—
+6K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp)20200—
+6K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…Medical Components, Inc. (dba MedComp)20181—