510(k) Report

Devices descending from K083214

10 later devices reach Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180864WATCHMAN TruSeal Access SystemBoston Scientific20182Class I
+1K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO20164—
+1K121611Amplatzer Torqvue FXAga Medical Corporation20120Class I
+1K120120Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer…Aga Medical Corporation20125—
+2K212026Amplatzer Steerable Delivery SheathAbbott Medical202131
+2K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation20211Class I
+3K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation20240Class I
+3K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+4K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+5K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—