510(k) Report

Devices descending from K203365

1 later device reach Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—