510(k) Report

Devices descending from K120120

5 later devices reach Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO20164—
+2K212026Amplatzer Steerable Delivery SheathAbbott Medical202131
+3K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+4K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+5K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—