510(k) Report

Devices descending from K101987

6 later devices reach Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.201634
+1K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc.2015421
+1K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+2K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20212—
+3K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20230—
+3K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20221—