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
+1K153771TXM Guiding SheathTexasmedical Technologies, Inc.20160—
+1K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc.200412
+1K012854Renal Guiding SheathTerumo Medical Corp.200182
+1K012812Carotid Guiding SheathTerumo Medical Corp.2001691
+1K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Datascope Corp.199817—
+1K973007Datascope's 10 FR. Flexisheath Percutaneous IntroducerDatascope Corp.19970—
+1K964814Bipore Accuflex Percutaneous Sheath IntroducerBipore, Inc.19972—
+1K963320TFX Medical GuidewireTfx Medical Group1996103—
+2K094062Percu-Pro GuidewireCardiosolutions, Inc.20100—
+2K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc.200806
+2K081045Destination Renal Guiding SheathTerumo Medical Corp.20085—
+2K062582Supracor Balloon CatheterAbiomed, Inc.20061—
+2K060666Carotid Access KitTerumo Medical Corp.20060—
+2K051513Bipore Accuflex Percutaneous Sheath IntroducerBipore, Inc.20051—
+2K052185Destination Carotid Guiding SheathTerumo Medical Corp.200571
+2K051601Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.200560—
+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—
+2K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…Datascope Corp.200015—
+3K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…Terumo Medical Corporation20170—
+3K171491R2P Destination Slender Guiding SheathTerumo Medical Corporation20173—
+3K140641Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, LimaBoston Scientific Corporation20140—
+3K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd.20130—
+3K122958Delivery Sheath, Model Adelante BreezewayOscor, Inc.2012230
+3K091329Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.2009301
+3K082746Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20Insightra Medical, Inc.200901
+3K081341Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc.200813—
+3K073434Bipore Accuflex Percutaneous Sheath IntroducerBipore, Inc.20080—
+3K080415Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.200844—
+3K070166Strada Carotid Guiding SheathSt Jude Medical20071—
+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—
+3K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Datascope Corp.200114—
+4K210627Breezeway IIOscor, Inc.20211—
+4K202167Brite Tip Radianz Guiding SheathCordis Corporation20210—
+4K193125R2P Destination Slender Guiding SheathTerumo Medical Corporation20201—
+4K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH20185—
+4K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…Smiths Medical Asd, Inc.20180Class I
+4K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…Cook Incorporated201513Class I
+4K142819Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer SetCook Incorporated20151—
+4K142357DuraSheath Introducer Sheath SystemContract Medical International, GmbH20156—
+4K150186Chariot Guiding SheathBoston Scientific Corp20150Class I
+4K133597Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…Cook, Inc.201421
+4K111004Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc.2012102
+4K112917Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery…Medtronic, Inc.20110—
+4K100799Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH201110—
+4K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.2010830
+4K101625Cohen Crossover CatheterVascular Solutions, Inc.20100—
+4K093130Engage TR IntroducerSt Jude Medical200905
+4K083031Portex Uniperc Percutaneous Dilation Tracheostomy KitSmiths Medical Asd, Inc.20090—
+4K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Datascope Corp., Cardiac Assist Division20093—
+4K090999Biocardia Morph Sheath GuideBiocardia, Inc.200903
+4K083269CrossoverThomas Medical Products, Inc.200902
+4K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc.200813—
+4K081046Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.20080—
+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—
+4K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp.20078Class I
+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—
+4K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp.2004117
+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—
+4K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp.200312—
+4K024032Attain 6216A-MP Multi-Purpose Guide Catheter for Left-Heart DeliveryMedtronic Vascular200214—
+4K020257Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True…Datascope Corp.20020—
+5K261242SimplGuidePendracare20260—
+5K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090…Pulnovo Medical (Wuxi) Co., Ltd.20240—
+5K23343210F Sheath and Dilator SetArgon Medical Devices, Inc.20230—
+5K221914Catapult Guide SheathContract Medical International, GmbH20222—
+5K211405Prelude Guide SheathMerit Medical Systems, Inc.202113
+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—
+5K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp.201702
+5K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical201661
+5K152999CorPath 200 SystemCorindus, Inc.20162—
+5K153430Flexor Tuohy-Borst Side-Arm Introducers Shuttle SelectCook Incorporated20160—
+5K153197Fortress Introducer Sheath SYstemContract Medical International, GmbH201621
+5K152225Edwards eSheath Introducer SetEdwards Lifesciences20154—
+5K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp.201309
+5K132369Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc.201392
+5K123153Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for…Medtronic, Ireland20133—
+5K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—