510(k) Report

Devices descending from K072313

30 later devices reach Amplatzer Torqvue Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260993Amplatzer TorqVue Delivery SystemAbbott20260—
+1K202610Ventrax Delivery SystemMerit Medical Systems, Inc.20202—
+1K190581Amplatzer Trevisio Intravascular Delivery SystemAbbott Medical20192—
+1K131063Amplatzer Torq Vue LP Delivery SystemSt Jude Medical201351
+1K121611Amplatzer Torqvue FXAga Medical Corporation20120Class I
+1K100184Fustar Steerable IntroducersLifetech Scientific (Shenzhen) Co., Ltd.20110—
+1K093476Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120…Aga Medical Corp.20100—
+1K091793Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54Aga Medical Corp.20090—
+1K083214Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100…Aga Medical Corp.200910—
+1K080994Amplatzer Torqvue Exchange SystemAga Medical Corp.20081—
+1K080757Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp.20087—
+2K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott20260—
+2K261631Amplatzer TorqVue Exchange SystemAbbott Medical20260—
+2K260499Amplatzer™ Trevisio™ Intravascular Delivery System…Abbott Medical20260—
+2K241538TriClip Steerable Guide CatheterAbbott Medical20241—
+2K231246Ventrax™ Delivery System (VTR851)Merit Medical Systems, Inc.20231—
+2K212738Amplatzer Talisman Delivery SheathAbbott Medical20210—
+2K180864WATCHMAN TruSeal Access SystemBoston Scientific20182Class I
+2K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO20164—
+2K162228TorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor201621
+2K120120Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer…Aga Medical Corporation20125—
+3K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)Abbott Medical20250—
+3K242873Ventrax™ Delivery SystemMerit Medical Systems, Inc.20250—
+3K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter…Abbott Medical20240—
+3K212026Amplatzer Steerable Delivery SheathAbbott Medical202131
+3K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation20211Class I
+4K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation20240Class I
+4K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+5K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+6K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—