510(k) Report

Devices descending from K212224

6 later devices reach TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230726CEREGLIDE 92 Intermediate CatheterCerenovus, Inc.20231—
+1K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20232—
+1K220807Imperative Care Radial 088 Access SystemImperative Care, Inc.20220—
+2K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20241—
+2K233982CEREGLIDE 92 Catheter SystemCerenovus, Inc.20240—
+3K252297Toro 88 Superbore CatheterToro Neurovascular, Inc.20260—