510(k) Report

Devices descending from K150107

29 later devices reach Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212288Minjie Catheter SystemKai Medtech, LLC20220—
+1K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access…Imperative Care, Inc.201827—
+2K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformImperative Care, Inc.20216—
+2K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal…Imperative Care, Inc.202117—
+2K200121Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc.20208—
+3K242051VersaD Delivery CatheterUnity Medical, Inc.20251—
+3K24097187 NeuGlide CatheterPiraeus Medical20242—
+3K230726CEREGLIDE 92 Intermediate CatheterCerenovus, Inc.20231—
+3K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20232—
+3K214048Millipede 088 Access CatheterPerfuze, Ltd.20226—
+3K220807Imperative Care Radial 088 Access SystemImperative Care, Inc.20220—
+3K201518Route 92 Medical 088 Access SystemRoute 92 Medical20205—
+4K26227770 NeuGlide CatheterPiraeus Medical, Inc.20260—
+4K251372VersaD Delivery CatheterUnity Medical, Inc.20250—
+4K25104493 NeuFlex CatheterPiraeus Medical20250—
+4K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20241—
+4K233982CEREGLIDE 92 Catheter SystemCerenovus, Inc.20240—
+4K231802Millipede 088 Access CatheterPerfuze, Ltd.20235—
+4K210635Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc.20213—
+4K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc.20200Class I
+5K252297Toro 88 Superbore CatheterToro Neurovascular, Inc.20260—
+5K233648Millipede 088 Access CatheterPerfuze, Ltd.20234—
+5K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc.20222Class I
+6K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+6K231583Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc.20231—
+7K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.20260—
+7K253901Millipede88 Access CatheterPerfuze, Ltd.20260—
+7K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20251—
+8K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—