510(k) Report

Devices descending from K212026

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+2K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+3K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—