510(k) Report

Devices descending from K924607

194 later devices reach Arrow Fischell Kink Resist Percut Sheath Intro Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC20113Class I
+5K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC201121
+5K101885Medtronic C315 Delivery CatheterMedtronic, Inc.201081
+5K100135GDS-DC12Guided Delivery Systems20100—
+5K093469Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple…Cook, Inc.2010017
+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—
+6K240957Catapult Guide SheathContract Medical International, GmbH20241—
+6K223872Low Profile Companion SheathMerit Medical Systems, Inc.20230—
+6K202610Ventrax Delivery SystemMerit Medical Systems, Inc.20202—
+6K203179Fortress Introducer Sheath SystemContract Medical International, GmbH20200—
+6K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc.20201—
+6K200258Edwards eSheath Introducer SetEdwards Lifesciences20202—
+6K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems20195—
+6K190581Amplatzer Trevisio Intravascular Delivery SystemAbbott Medical20192—
+6K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.20180Class I
+6K171820Transjugular Liver Access SetsCook Incorporated201852
+6K173288CorPath GRX SystemCorindus, Inc.20181—
+6K171819Attain Assist CS Access CatheterCreganna Medical Also Doing Business AS Ceganna Tactx Medica20180—
+6K170616van Andel Dilatation CatheterCook Incorporated20170—
+6K162184Edwards eSheath Introducer SetEdward Lifesciences20163—
+6K151951Destino ReachOscor, Inc.20156—
+6K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.20151Class I
+6K141614Magellan Robotic SystemHansen Medical201452
+6K133552Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR…Hansen Medical20142—
+6K131063Amplatzer Torq Vue LP Delivery SystemSt Jude Medical201351
+6K122960Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+6K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division201203
+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—
+7K244046Edwards eSheath Optima introducer setEdwards Lifesciences20251—
+7K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm…Contract Medical International, GmbH20250—
+7K241538TriClip Steerable Guide CatheterAbbott Medical20241—
+7K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+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—
+7K221440Liverty™ TIPS Access SetBard Peripheral Vascular, Inc.20220—
+7K212738Amplatzer Talisman Delivery SheathAbbott Medical20210—
+7K202141Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access SetArgon Medical Devices, Inc.202111
+7K201489Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein…Argon Medical Devices, Inc.20201—
+7K180864WATCHMAN TruSeal Access SystemBoston Scientific20182Class I
+7K180517CorPath GRX SystemCorindus, Inc.20180—
+7K171557AcQRef Introducer SheathAcutus Medical, Inc.20181—
+7K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…Datascope Corp.20170Class I
+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
+7K151463Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsHansen Medical, Inc.20151—
+7K151730Magellan Robotic SystemHansen Medical, Inc.201511
+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—
+8K243789LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical, Ltd.20250—
+8K252364Edwards eSheath Optima introducer setEdwards Lifesciences20250—
+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—
+8K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+8K213638Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein…Argon Medical Devices20210—
+8K213002SCORPION Portal Vein Access SetArgon Medical Devices20210—
+8K212026Amplatzer Steerable Delivery SheathAbbott Medical202131
+8K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation20211Class I
+8K192106AcQRef Introducer SheathAcutus Medical, Inc.20190—
+8K153304Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc.20160—
+9K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—
+9K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+9K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation20240Class I
+9K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+10K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+10K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+10K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+11K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—
+11K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—