510(k) Report

Devices descending from K110055

54 later devices reach Reverse Medical Reflex Guide Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182097React 71 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20182—
+1K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular201819—
+1K171672065 Zenith, 074 ZenithInneuroco, Inc.20171—
+1K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular201629—
+1K150107Arc Intracranial Support Catheter, Arc Mini Intracranial Support CatheterMicro Therapeutics Inc Dba Ev3 Neurovascular201529—
+2K241177React 71 CatheterMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20240—
+2K231056Esperance Distal Access CatheterWallaby Medical20240—
+2K231218Distal Access CatheterAccumedical Beijing, Ltd.20240—
+2K212288Minjie Catheter SystemKai Medtech, LLC20220—
+2K220716Spartan SC 069Spartan Micro, Inc.20220—
+2K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…Stryker201914—
+2K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access…Imperative Care, Inc.201827—
+2K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc.20180—
+3K251097V-DAC CatheterVesalio, Inc.20260—
+3K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformImperative Care, Inc.20216—
+3K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal…Imperative Care, Inc.202117—
+3K200121Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc.20208—
+3K190833AXS Vecta Aspiration CatheterStryker Neurovascular20196—
+3K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc.20195—
+4K242051VersaD Delivery CatheterUnity Medical, Inc.20251—
+4K24097187 NeuGlide CatheterPiraeus Medical20242—
+4K230726CEREGLIDE 92 Intermediate CatheterCerenovus, Inc.20231—
+4K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20232—
+4K221930CEREGLIDE 71 Intermediate CatheterCerenovus, Inc.20231—
+4K214048Millipede 088 Access CatheterPerfuze, Ltd.20226—
+4K220807Imperative Care Radial 088 Access SystemImperative Care, Inc.20220—
+4K202752AXS Vecta 46 Intermediate CatheterStryker Neurovascular20213—
+4K201518Route 92 Medical 088 Access SystemRoute 92 Medical20205—
+4K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+4K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterStryker Neurovascular20201—
+5K26227770 NeuGlide CatheterPiraeus Medical, Inc.20260—
+5K261176Zoom 4S CatheterImperative Care, Inc.20260—
+5K251372VersaD Delivery CatheterUnity Medical, Inc.20250—
+5K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.20250—
+5K25104493 NeuFlex CatheterPiraeus Medical20250—
+5K241768Broadway 8 CatheterStryker Neurovascular20240—
+5K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc.20241—
+5K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20241—
+5K233982CEREGLIDE 92 Catheter SystemCerenovus, Inc.20240—
+5K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20240—
+5K231802Millipede 088 Access CatheterPerfuze, Ltd.20235—
+5K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20231—
+5K210635Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc.20213—
+5K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc.20200Class I
+6K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.20260—
+6K252297Toro 88 Superbore CatheterToro Neurovascular, Inc.20260—
+6K233648Millipede 088 Access CatheterPerfuze, Ltd.20234—
+6K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc.20222Class I
+7K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+7K231583Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc.20231—
+8K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.20260—
+8K253901Millipede88 Access CatheterPerfuze, Ltd.20260—
+8K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20251—
+9K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—