510(k) Report

Devices descending from K002577

26 later devices reach Arctic Sun Temperature Management System, Model 100 Control Unit and Patient… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc.201446
+1K033021Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer PadsKimberly-Clark Corp.200332
+1K022366Celsius Control SystemInnercool Therapies200316—
+2K161602Arctic Sun Temperature Management SystemMedivance, Inc.201632
+2K071358Reprieve Endovascular Temperature Therapy SystemRadiant Medical20070—
+2K062794PRN Thermalcare, Model 3000American Healthcare Products, Inc.20062—
+2K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp.2003154
+3K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.20250—
+3K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.202011
+3K113705Pintler Patient Warming SystemPintler Medical201201
+3K081936Solex Catheter, Model SL2593Alsius Corp.20085—
+3K080763Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HTTalley Medical20080—
+3K052443Icy Catheter, Model IC-3893AAlsius Corp.20058—
+3K051912Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…Alsius Corp.20050—
+3K033623Celsius Control SystemInnercool Therapies, Inc.20042—
+4K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.20250—
+4K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+4K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation20106—
+4K080908Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation200811
+4K070161Quattro Catheter Model IC4593Alsius Corp.20077—
+5K152946TempedySeiratherm GmbH20160—
+5K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.201634
+5K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc.2015421
+6K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20212—
+7K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20230—
+7K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20221—