510(k) Report

Devices descending from K220340

2 later devices reach Amplatzer Steerable Delivery Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+2K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—