510(k) Report

Devices descending from K163000

4 later devices reach AMPLATZER TorqVue 45x45 Delivery Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212026Amplatzer Steerable Delivery SheathAbbott Medical202131
+2K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+3K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+4K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—