510(k) Report

Devices descending from K152876

13 later devices reach Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191717Route 92 Medical Sheath SystemRoute 92 Medical, Inc.20202—
+1K191551RIST Cath Radial Access Long SheathRist Neurovascular, Inc.20196—
+1K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc.201721
+2K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+2K242376Next Generation Access PlatformBalt USA, LLC20240Class I
+2K2405298F Modified Sheath SystemRoute 92 Medical, Inc.20240—
+2K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc.20232—
+2K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+2K193034AXS Infinity LS Plus Long SheathStryker Neurovascular20191—
+3K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+3K253975Radical 6F Access CatheterMaduro Medical, Inc.20260—
+3K243577Radical the Dude 8F Guide CatheterMaduro Medical, Inc.20250—
+3K241637Echo Intracranial Base CatheterStryker Neurovascular20240—