510(k) Report

Devices descending from K935198

104 later devices reach Gastroenterology and Urology Guidewire Modifications through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963320TFX Medical GuidewireTfx Medical Group1996103—
+2K094062Percu-Pro GuidewireCardiosolutions, Inc.20100—
+2K043446Emmebi Central Venous Catheter Kit with Lestep Safety IntroducerEmmebi Srl20050—
+2K022212Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited200310—
+2K012083Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular200189—
+3K053400Acumen Single-Lumen Delivery SheathAcumen Medical, Inc.200611—
+3K0524596248VAL Adjustable ValveMedtronic Vascular200601
+3K041044Ciaglia Cheetah Percutaneous Tracheostomy Introducer SetCook, Inc.20042—
+3K041348Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single…Smiths Medical200451
+3K040014Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers…Portex, Ltd.20046—
+3K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular200337—
+3K023937Cook Vascular Serpenta Coronary Sinus Introducer SystemCook Vascular, Inc.20030—
+3K021587Attain LDS 6216A Left-Heart Delivery System, Model 6216AMedtronic Vascular2002311
+3K021589Attain Access 6218A Left-Heart Delivery System, Model 6218Medtronic Vascular2002311
+3K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular200280—
+4K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…Smiths Medical Asd, Inc.20180Class I
+4K133597Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…Cook, Inc.201421
+4K112917Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery…Medtronic, Inc.20110—
+4K083031Portex Uniperc Percutaneous Dilation Tracheostomy KitSmiths Medical Asd, Inc.20090—
+4K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc.200813—
+4K080500Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7Acumen Medical, Inc.20089—
+4K072148Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy IntroducerCook, Inc.20071—
+4K070396Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45Acumen Medical, Inc.200710—
+4K061416Selectsite C304 Deflectable Catheter System, Models C304-S59, C304-L69, C304-XS59 &…Medtronic Vascular20061—
+4K061480Attain 6227DEF Deflectable Catheter Delivery SystemMedtronic, Ireland20060—
+4K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland200614—
+4K053277CPS Direct SL Outer CatheterSt Jude Medical200601
+4K043489Enpath Deflectable CatheterEnpath Medical Incorporated2005132
+4K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular200417—
+4K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management200435—
+4K032622Attain Prevail Left Heart Delivery System Moddel, 6228SYSMedtronic Vascular20035—
+4K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular200329—
+4K024032Attain 6216A-MP Multi-Purpose Guide Catheter for Left-Heart DeliveryMedtronic Vascular200214—
+5K200721Agilis HisPro Steerable Catheter With ElectrodesAbbott (St. Jude Medical)20200—
+5K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…Cook Incorporated20190Class I
+5K183493SelectSite C304-HIS Deflectable Catheter SystemMedtronic, Inc.201901
+5K180034Weinmann Tracheostomy Exchange SetCook Incorporated20181—
+5K123153Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for…Medtronic, Ireland20133—
+5K101885Medtronic C315 Delivery CatheterMedtronic, Inc.201081
+5K100135GDS-DC12Guided Delivery Systems20100—
+5K093469Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple…Cook, Inc.2010017
+5K090999Biocardia Morph Sheath GuideBiocardia, Inc.200903
+5K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc.200912—
+5K082670Modification to: Attain Prevail 6228CTH80 Steerable Catheter SetMedtronic, Inc.20080—
+5K072313Amplatzer Torqvue Delivery SystemAga Medical Corp.2007301
+5K070238Amplatzer Reliant Catheter Delivery SystemAga Medical Corp.20070—
+5K061119Enpath Medical Steerable SheathEnpath Medical, Inc.200610—
+5K053217CPS Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147…St Jude Medical200605
+5K052575Luminary Cannulator Bideflectable Catheter with LumenSt Jude Medical20064—
+5K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc.20043—
+6K260993Amplatzer TorqVue Delivery SystemAbbott20260—
+6K202610Ventrax Delivery SystemMerit Medical Systems, Inc.20202—
+6K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc.20201—
+6K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems20195—
+6K190581Amplatzer Trevisio Intravascular Delivery SystemAbbott Medical20192—
+6K171819Attain Assist CS Access CatheterCreganna Medical Also Doing Business AS Ceganna Tactx Medica20180—
+6K131063Amplatzer Torq Vue LP Delivery SystemSt Jude Medical201351
+6K122960Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+6K121611Amplatzer Torqvue FXAga Medical Corporation20120Class I
+6K103083Agilis ES Steerable IntroducerSt Jude Medical20112—
+6K100184Fustar Steerable IntroducersLifetech Scientific (Shenzhen) Co., Ltd.20110—
+6K101784Mobicath BI-Directional Guiding Sheath Model 1000182-XXXGreat Batch Medical201003
+6K093476Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120…Aga Medical Corp.20100—
+6K091793Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54Aga Medical Corp.20090—
+6K083214Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100…Aga Medical Corp.200910—
+6K080994Amplatzer Torqvue Exchange SystemAga Medical Corp.20081—
+6K080757Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp.20087—
+6K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc.20070—
+6K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc.20051—
+7K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott20260—
+7K261631Amplatzer TorqVue Exchange SystemAbbott Medical20260—
+7K260499Amplatzer™ Trevisio™ Intravascular Delivery System…Abbott Medical20260—
+7K250492FlexiGo 3D Delivery CatheterCenterPoint Systems, LLC20250—
+7K241538TriClip Steerable Guide CatheterAbbott Medical20241—
+7K231246Ventrax™ Delivery System (VTR851)Merit Medical Systems, Inc.20231—
+7K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC20233—
+7K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemMedtronic20220—
+7K212738Amplatzer Talisman Delivery SheathAbbott Medical20210—
+7K180864WATCHMAN TruSeal Access SystemBoston Scientific20182Class I
+7K171557AcQRef Introducer SheathAcutus Medical, Inc.20181—
+7K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO20164—
+7K162228TorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor201621
+7K151951Destino ReachOscor, Inc.20156—
+7K120120Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer…Aga Medical Corporation20125—
+7K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.20060—
+8K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)Abbott Medical20250—
+8K250147CPS Locator 3D Delivery CatheterCenterpoint Systems20250—
+8K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20251—
+8K242873Ventrax™ Delivery SystemMerit Medical Systems, Inc.20250—
+8K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter…Abbott Medical20240—
+8K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+8K212026Amplatzer Steerable Delivery SheathAbbott Medical202131
+8K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation20211Class I
+8K192106AcQRef Introducer SheathAcutus Medical, Inc.20190—
+9K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—
+9K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+9K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation20240Class I
+9K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+10K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+10K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—