510(k) Report

Devices descending from K030270

10 later devices reach 3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171994Silicone Peripherally Inserted Central Venous Catheter Set/TrayCook Incorporated20180—
+1K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.20123—
+1K062425Lifecath S Picc and Midline CatheterVygon Corp.200602
+1K031689Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc.20033—
+2K233515Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended…Nuwellis, Inc.20231—
+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—
+2K0417915.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc.20042—
+3K252226Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended…Nuwellis, Inc.20250—
+3K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—