510(k) Report

Devices descending from K203764

17 later devices reach TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K24097187 NeuGlide CatheterPiraeus Medical20242—
+1K214048Millipede 088 Access CatheterPerfuze, Ltd.20226—
+1K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformImperative Care, Inc.20216—
+2K26227770 NeuGlide CatheterPiraeus Medical, Inc.20260—
+2K25104493 NeuFlex CatheterPiraeus Medical20250—
+2K230726CEREGLIDE 92 Intermediate CatheterCerenovus, Inc.20231—
+2K231802Millipede 088 Access CatheterPerfuze, Ltd.20235—
+2K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20232—
+2K220807Imperative Care Radial 088 Access SystemImperative Care, Inc.20220—
+3K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20241—
+3K233982CEREGLIDE 92 Catheter SystemCerenovus, Inc.20240—
+3K233648Millipede 088 Access CatheterPerfuze, Ltd.20234—
+4K252297Toro 88 Superbore CatheterToro Neurovascular, Inc.20260—
+4K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+5K253901Millipede88 Access CatheterPerfuze, Ltd.20260—
+5K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20251—
+6K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—