510(k) Report

Devices descending from K993933

8 later devices reach 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.)20150Class I
+1K122091Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute…Cook, Inc.20131—
+1K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc.20060—
+1K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc.20061—
+1K011761Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral…Arrow Intl., Inc.20011Class I
+2K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated20170—
+2K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc.200702
+2K032962AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial SurfaceArrow Intl., Inc.20030—