510(k) Report

Devices descending from K010128

38 later devices reach Cook Vascular Peel-Away Hemostasis Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management200435—
+1K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular200337—
+2K200721Agilis HisPro Steerable Catheter With ElectrodesAbbott (St. Jude Medical)20200—
+2K183493SelectSite C304-HIS Deflectable Catheter SystemMedtronic, Inc.201901
+2K072313Amplatzer Torqvue Delivery SystemAga Medical Corp.2007301
+2K070238Amplatzer Reliant Catheter Delivery SystemAga Medical Corp.20070—
+2K061416Selectsite C304 Deflectable Catheter System, Models C304-S59, C304-L69, C304-XS59 &…Medtronic Vascular20061—
+2K061480Attain 6227DEF Deflectable Catheter Delivery SystemMedtronic, Ireland20060—
+3K260993Amplatzer TorqVue Delivery SystemAbbott20260—
+3K202610Ventrax Delivery SystemMerit Medical Systems, Inc.20202—
+3K190581Amplatzer Trevisio Intravascular Delivery SystemAbbott Medical20192—
+3K131063Amplatzer Torq Vue LP Delivery SystemSt Jude Medical201351
+3K121611Amplatzer Torqvue FXAga Medical Corporation20120Class I
+3K100184Fustar Steerable IntroducersLifetech Scientific (Shenzhen) Co., Ltd.20110—
+3K093476Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120…Aga Medical Corp.20100—
+3K091793Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54Aga Medical Corp.20090—
+3K083214Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100…Aga Medical Corp.200910—
+3K080994Amplatzer Torqvue Exchange SystemAga Medical Corp.20081—
+3K080757Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp.20087—
+4K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott20260—
+4K261631Amplatzer TorqVue Exchange SystemAbbott Medical20260—
+4K260499Amplatzer™ Trevisio™ Intravascular Delivery System…Abbott Medical20260—
+4K241538TriClip Steerable Guide CatheterAbbott Medical20241—
+4K231246Ventrax™ Delivery System (VTR851)Merit Medical Systems, Inc.20231—
+4K212738Amplatzer Talisman Delivery SheathAbbott Medical20210—
+4K180864WATCHMAN TruSeal Access SystemBoston Scientific20182Class I
+4K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO20164—
+4K162228TorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor201621
+4K120120Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer…Aga Medical Corporation20125—
+5K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)Abbott Medical20250—
+5K242873Ventrax™ Delivery SystemMerit Medical Systems, Inc.20250—
+5K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter…Abbott Medical20240—
+5K212026Amplatzer Steerable Delivery SheathAbbott Medical202131
+5K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation20211Class I
+6K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation20240Class I
+6K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+7K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+8K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—