510(k) Report

Devices descending from K012512

27 later devices reach Setpoint Endovascular Temperature Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071358Reprieve Endovascular Temperature Therapy SystemRadiant Medical20070—
+1K063405Reprieve Endovascular Temperature Therapy SystemRadiant Medical20071—
+1K033623Celsius Control SystemInnercool Therapies, Inc.20042—
+1K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp.2003154
+1K024327Setpoint Endovascular Temperature ProbeRadiant Medical20031—
+1K023914Coaxia Flocontrol CatheterCoaxia, Inc.20036—
+1K022366Celsius Control SystemInnercool Therapies200316—
+2K090970Flocontrol , Model 1028Coaxia, Inc.20091—
+2K080908Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation200811
+2K080700Duoflo CatheterThermopeutix, Inc.20083—
+2K081936Solex Catheter, Model SL2593Alsius Corp.20085—
+2K052443Icy Catheter, Model IC-3893AAlsius Corp.20058—
+2K051912Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…Alsius Corp.20050—
+2K042388Radiant Medical Endocatheter Temperature ProbeRadiant Medical20040—
+3K192786Gatekeeper Balloon CatheterArch Catheter, LLC20200—
+3K152946TempedySeiratherm GmbH20160—
+3K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+3K112219Tapas CatheterThermopeutix, Inc.20111—
+3K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation20106—
+3K093847Duflo Catheter (Heparin Coated)Thermopeutix, Inc.20100—
+3K070161Quattro Catheter Model IC4593Alsius Corp.20077—
+4K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.201634
+4K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc.2015421
+4K141175Renovocath RC120Renovorx, Inc.201401
+5K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20212—
+6K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20230—
+6K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20221—