510(k) Report

Devices descending from K091329

30 later devices reach Pinnacle Destination Peripheral Guiding Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH20185—
+1K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…Terumo Medical Corporation20170—
+1K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…Cook Incorporated201513Class I
+1K142819Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer SetCook Incorporated20151—
+1K142357DuraSheath Introducer Sheath SystemContract Medical International, GmbH20156—
+1K150186Chariot Guiding SheathBoston Scientific Corp20150Class I
+1K100799Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH201110—
+1K101625Cohen Crossover CatheterVascular Solutions, Inc.20100—
+2K23343210F Sheath and Dilator SetArgon Medical Devices, Inc.20230—
+2K221914Catapult Guide SheathContract Medical International, GmbH20222—
+2K211405Prelude Guide SheathMerit Medical Systems, Inc.202113
+2K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical201661
+2K153430Flexor Tuohy-Borst Side-Arm Introducers Shuttle SelectCook Incorporated20160—
+2K153197Fortress Introducer Sheath SYstemContract Medical International, GmbH201621
+2K152225Edwards eSheath Introducer SetEdwards Lifesciences20154—
+3K240957Catapult Guide SheathContract Medical International, GmbH20241—
+3K223872Low Profile Companion SheathMerit Medical Systems, Inc.20230—
+3K203179Fortress Introducer Sheath SystemContract Medical International, GmbH20200—
+3K200258Edwards eSheath Introducer SetEdwards Lifesciences20202—
+3K171820Transjugular Liver Access SetsCook Incorporated201852
+3K170616van Andel Dilatation CatheterCook Incorporated20170—
+3K162184Edwards eSheath Introducer SetEdward Lifesciences20163—
+4K244046Edwards eSheath Optima introducer setEdwards Lifesciences20251—
+4K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm…Contract Medical International, GmbH20250—
+4K221440Liverty™ TIPS Access SetBard Peripheral Vascular, Inc.20220—
+4K202141Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access SetArgon Medical Devices, Inc.202111
+4K201489Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein…Argon Medical Devices, Inc.20201—
+5K252364Edwards eSheath Optima introducer setEdwards Lifesciences20250—
+5K213638Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein…Argon Medical Devices20210—
+5K213002SCORPION Portal Vein Access SetArgon Medical Devices20210—