510(k) Report

Devices descending from K012812

69 later devices reach Carotid Guiding Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060666Carotid Access KitTerumo Medical Corp.20060—
+1K052185Destination Carotid Guiding SheathTerumo Medical Corp.200571
+1K051601Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.200560—
+2K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…Terumo Medical Corporation20170—
+2K171491R2P Destination Slender Guiding SheathTerumo Medical Corporation20173—
+2K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd.20130—
+2K091329Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.2009301
+2K081341Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc.200813—
+2K080415Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.200844—
+2K070166Strada Carotid Guiding SheathSt Jude Medical20071—
+3K202167Brite Tip Radianz Guiding SheathCordis Corporation20210—
+3K193125R2P Destination Slender Guiding SheathTerumo Medical Corporation20201—
+3K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH20185—
+3K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…Cook Incorporated201513Class I
+3K142819Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer SetCook Incorporated20151—
+3K142357DuraSheath Introducer Sheath SystemContract Medical International, GmbH20156—
+3K150186Chariot Guiding SheathBoston Scientific Corp20150Class I
+3K122958Delivery Sheath, Model Adelante BreezewayOscor, Inc.2012230
+3K111004Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc.2012102
+3K100799Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH201110—
+3K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.2010830
+3K101625Cohen Crossover CatheterVascular Solutions, Inc.20100—
+3K093130Engage TR IntroducerSt Jude Medical200905
+3K090999Biocardia Morph Sheath GuideBiocardia, Inc.200903
+3K083269CrossoverThomas Medical Products, Inc.200902
+3K081046Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.20080—
+4K261242SimplGuidePendracare20260—
+4K23343210F Sheath and Dilator SetArgon Medical Devices, Inc.20230—
+4K221914Catapult Guide SheathContract Medical International, GmbH20222—
+4K211405Prelude Guide SheathMerit Medical Systems, Inc.202113
+4K210627Breezeway IIOscor, Inc.20211—
+4K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical201661
+4K152999CorPath 200 SystemCorindus, Inc.20162—
+4K153430Flexor Tuohy-Borst Side-Arm Introducers Shuttle SelectCook Incorporated20160—
+4K153197Fortress Introducer Sheath SYstemContract Medical International, GmbH201621
+4K152225Edwards eSheath Introducer SetEdwards Lifesciences20154—
+4K132369Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc.201392
+4K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+5K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090…Pulnovo Medical (Wuxi) Co., Ltd.20240—
+5K240957Catapult Guide SheathContract Medical International, GmbH20241—
+5K223872Low Profile Companion SheathMerit Medical Systems, Inc.20230—
+5K203179Fortress Introducer Sheath SystemContract Medical International, GmbH20200—
+5K200258Edwards eSheath Introducer SetEdwards Lifesciences20202—
+5K171820Transjugular Liver Access SetsCook Incorporated201852
+5K173288CorPath GRX SystemCorindus, Inc.20181—
+5K170616van Andel Dilatation CatheterCook Incorporated20170—
+5K162184Edwards eSheath Introducer SetEdward Lifesciences20163—
+5K151951Destino ReachOscor, Inc.20156—
+5K141614Magellan Robotic SystemHansen Medical201452
+5K133552Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR…Hansen Medical20142—
+6K244046Edwards eSheath Optima introducer setEdwards Lifesciences20251—
+6K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm…Contract Medical International, GmbH20250—
+6K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+6K221440Liverty™ TIPS Access SetBard Peripheral Vascular, Inc.20220—
+6K202141Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access SetArgon Medical Devices, Inc.202111
+6K201489Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein…Argon Medical Devices, Inc.20201—
+6K180517CorPath GRX SystemCorindus, Inc.20180—
+6K151463Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsHansen Medical, Inc.20151—
+6K151730Magellan Robotic SystemHansen Medical, Inc.201511
+7K243789LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical, Ltd.20250—
+7K252364Edwards eSheath Optima introducer setEdwards Lifesciences20250—
+7K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+7K213638Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein…Argon Medical Devices20210—
+7K213002SCORPION Portal Vein Access SetArgon Medical Devices20210—
+7K153304Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc.20160—
+8K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+9K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+9K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+10K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—