510(k) Report

Devices descending from K080415

44 later devices reach Device Modification to Pinnacle Destination Peripheral Guiding Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111004Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc.2012102
+1K091329Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.2009301
+1K090999Biocardia Morph Sheath GuideBiocardia, Inc.200903
+1K081046Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.20080—
+2K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH20185—
+2K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…Terumo Medical Corporation20170—
+2K152999CorPath 200 SystemCorindus, Inc.20162—
+2K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…Cook Incorporated201513Class I
+2K142819Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer SetCook Incorporated20151—
+2K142357DuraSheath Introducer Sheath SystemContract Medical International, GmbH20156—
+2K150186Chariot Guiding SheathBoston Scientific Corp20150Class I
+2K132369Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc.201392
+2K100799Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH201110—
+2K101625Cohen Crossover CatheterVascular Solutions, Inc.20100—
+3K23343210F Sheath and Dilator SetArgon Medical Devices, Inc.20230—
+3K221914Catapult Guide SheathContract Medical International, GmbH20222—
+3K211405Prelude Guide SheathMerit Medical Systems, Inc.202113
+3K173288CorPath GRX SystemCorindus, Inc.20181—
+3K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical201661
+3K153430Flexor Tuohy-Borst Side-Arm Introducers Shuttle SelectCook Incorporated20160—
+3K153197Fortress Introducer Sheath SYstemContract Medical International, GmbH201621
+3K152225Edwards eSheath Introducer SetEdwards Lifesciences20154—
+3K141614Magellan Robotic SystemHansen Medical201452
+3K133552Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR…Hansen Medical20142—
+4K240957Catapult Guide SheathContract Medical International, GmbH20241—
+4K223872Low Profile Companion SheathMerit Medical Systems, Inc.20230—
+4K203179Fortress Introducer Sheath SystemContract Medical International, GmbH20200—
+4K200258Edwards eSheath Introducer SetEdwards Lifesciences20202—
+4K180517CorPath GRX SystemCorindus, Inc.20180—
+4K171820Transjugular Liver Access SetsCook Incorporated201852
+4K170616van Andel Dilatation CatheterCook Incorporated20170—
+4K162184Edwards eSheath Introducer SetEdward Lifesciences20163—
+4K151463Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsHansen Medical, Inc.20151—
+4K151730Magellan Robotic SystemHansen Medical, Inc.201511
+5K243789LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical, Ltd.20250—
+5K244046Edwards eSheath Optima introducer setEdwards Lifesciences20251—
+5K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm…Contract Medical International, GmbH20250—
+5K221440Liverty™ TIPS Access SetBard Peripheral Vascular, Inc.20220—
+5K202141Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access SetArgon Medical Devices, Inc.202111
+5K201489Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein…Argon Medical Devices, Inc.20201—
+5K153304Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc.20160—
+6K252364Edwards eSheath Optima introducer setEdwards Lifesciences20250—
+6K213638Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein…Argon Medical Devices20210—
+6K213002SCORPION Portal Vein Access SetArgon Medical Devices20210—