510(k) Report

Devices descending from K011040

104 later devices reach Cryocare Cardiac Surgical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+9K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+9K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+9K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—