510(k) Report

Devices descending from K895417

23 later devices reach Arrow Large-Bore Dual Lumen Hemodialysis Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue…Arrow Intl., Inc.20008Class I
+1K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc.199713Class I
+2K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.)20150Class I
+2K122091Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute…Cook, Inc.20131—
+2K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc.20060—
+2K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc.20061—
+2K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp.2003116
+2K013182Triple Lumen Central Venous CatheterCook, Inc.20020—
+2K011761Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral…Arrow Intl., Inc.20011Class I
+3K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated20170—
+3K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.201634
+3K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc.2015421
+3K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation20106—
+3K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc.200702
+3K051912Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…Alsius Corp.20050—
+3K033623Celsius Control SystemInnercool Therapies, Inc.20042—
+3K032962AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial SurfaceArrow Intl., Inc.20030—
+4K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20212—
+4K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+4K080908Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation200811
+5K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20230—
+5K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20221—
+5K152946TempedySeiratherm GmbH20160—