510(k) Report

Devices descending from K030421

15 later devices reach Alsius Coolgard 3000 & Alsius Catheter System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081936Solex Catheter, Model SL2593Alsius Corp.20085—
+1K071358Reprieve Endovascular Temperature Therapy SystemRadiant Medical20070—
+1K052443Icy Catheter, Model IC-3893AAlsius Corp.20058—
+1K051912Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…Alsius Corp.20050—
+1K033623Celsius Control SystemInnercool Therapies, Inc.20042—
+2K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+2K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation20106—
+2K080908Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation200811
+2K070161Quattro Catheter Model IC4593Alsius Corp.20077—
+3K152946TempedySeiratherm GmbH20160—
+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
+4K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20212—
+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—