510(k) Report

Devices descending from K080583

38 later devices reach Modified HD Guide Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110483Modified HD Guide CatheterConcentric Medical, Inc.2011321
+1K092298Modification to Modified HD Guide CatheterConcentric Medical, Inc.20090—
+1K090335HD Guide CatheterConcentric Medical, Inc.200936—
+2K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Stryker2015263
+2K141981Asahi Fubuki 043 / Asahi FubukiAsahi Intecc Co., Ltd.20152—
+2K140557Mivi 6F Guide CatheterMivi, LLC20142—
+2K133177Modified HD Guide CatheterConcentric Medical, Inc.2014283
+3K242301Socrates 38 CatheterScientia Vascular, Inc.20240—
+3K234115APRO 55 CatheterAlembic, LLC20244—
+3K233205Distal Access CatheterShanghai Heartcare Medical Technology Co., Ltd.20230—
+3K213589FUBUKI XF Neurovascular Long SheathAsahi Intecc Co., Ltd.20221—
+3K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…Stryker201914—
+3K182097React 71 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20182—
+3K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular201819—
+3K151396MIVI Mi-AXUS Guide CatheterMivi Neuroscience, Inc.201512
+4K251097V-DAC CatheterVesalio, Inc.20260—
+4K251560FUBUKI XF-R Neurovascular Long SheathAsahi Intecc Co., Ltd.20250—
+4K251014APRO 45 CatheterAlembic, LLC20251—
+4K250962APRO 55 Intermediate CatheterAlembic, LLC20250—
+4K243297APRO 70 Swift CatheterAlembic, LLC20250—
+4K241177React 71 CatheterMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20240—
+4K231056Esperance Distal Access CatheterWallaby Medical20240—
+4K220716Spartan SC 069Spartan Micro, Inc.20220—
+4K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc.20200—
+4K190833AXS Vecta Aspiration CatheterStryker Neurovascular20196—
+4K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc.20195—
+5K262392APRO 35 Swift CatheterAlembic, LLC20260—
+5K221930CEREGLIDE 71 Intermediate CatheterCerenovus, Inc.20231—
+5K202752AXS Vecta 46 Intermediate CatheterStryker Neurovascular20213—
+5K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+5K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterStryker Neurovascular20201—
+6K261176Zoom 4S CatheterImperative Care, Inc.20260—
+6K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.20250—
+6K241768Broadway 8 CatheterStryker Neurovascular20240—
+6K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc.20241—
+6K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20240—
+6K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20231—
+7K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.20260—