510(k) Report

Devices descending from K974236

24 later devices reach Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063355D-Line Catheter ST, Double Lumen ST; Extra FlowNovosci Corp.20071—
+1K031689Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc.20033—
+1K023874System 100 Ultrafiltration CatheterChf Solutions, Inc.20030—
+1K991320Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc.199916—
+2K233515Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended…Nuwellis, Inc.20231—
+2K102833Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd.20110—
+2K100451Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin…Gambro Renal Products, Inc.20100—
+2K060509Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin CoatingTyco Healthcare Group200674
+2K0417915.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc.20042—
+2K023914Coaxia Flocontrol CatheterCoaxia, Inc.20036—
+3K252226Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended…Nuwellis, Inc.20250—
+3K112477Palindrome H, SI, Hsi Chronic CatheterCovidien20115Class I
+3K090970Flocontrol , Model 1028Coaxia, Inc.20091—
+3K080700Duoflo CatheterThermopeutix, Inc.20083—
+3K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…Kendall2006624
+4K192786Gatekeeper Balloon CatheterArch Catheter, LLC20200—
+4K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien20134Class I
+4K112219Tapas CatheterThermopeutix, Inc.20111—
+4K093847Duflo Catheter (Heparin Coated)Thermopeutix, Inc.20100—
+5K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical20143—
+5K141175Renovocath RC120Renovorx, Inc.201401
+6K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.)20172—
+7K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp)20200—
+7K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…Medical Components, Inc. (dba MedComp)20181—