510(k) Report

Devices descending from K984500

26 later devices reach Cordis Brite Tip Catheter Sheath Introducer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161183Halo One Thin-Walled Guiding SheathC.R. Bard, Inc.20162Class I
+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—
+1K020316Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator…Cordis Corp.20026—
+2K23343210F Sheath and Dilator SetArgon Medical Devices, Inc.20230—
+2K192313Halo One Thin-Walled Guiding SheathC.R. Bard, Inc.20191—
+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—
+2K152225Edwards eSheath Introducer SetEdwards Lifesciences20154—
+2K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…Cordis Corporation20045Class I
+3K212708Halo One Thin-Walled Guiding SheathC.R. Bard, Inc.20210—
+3K200258Edwards eSheath Introducer SetEdwards Lifesciences20202—
+3K171820Transjugular Liver Access SetsCook Incorporated201852
+3K162875Sentry IVC filterNovate Medical, Ltd.20172—
+3K162184Edwards eSheath Introducer SetEdward Lifesciences20163—
+3K140286Optease Vena Cava Filter and Optease Retrieval CathteterCordis, A Johnson & Johnson Co.20140—
+3K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co.20101Class I
+4K244046Edwards eSheath Optima introducer setEdwards Lifesciences20251—
+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—
+4K173236Sentry IVC FilterNovate Medical, Ltd.20181—
+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—
+5K181202Sentry IVC FilterNovate Medical, Ltd.20180—