510(k) Report

Devices descending from K142321

16 later devices reach Benchmark Intracranial Access System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233201MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)Penumbra, Inc.20240—
+1K212838Benchmark Intracranial Access SystemPenumbra, Inc.20227—
+1K200417RIST Radial Access CatheterRist Neurovascular, Inc.20203—
+1K181000SelectFlex 072 Neurovascular Access SystemQ'Apel20183—
+2K243593AXS Lift Intracranial Base CatheterStryker Neurovascular20251—
+2K240746Neurovascular Access System FamilyQ'Apel Medical, Inc.20240—
+2K230322SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc.20230—
+2K221822BENCHMARK BMX81 Access SystemPenumbra, Inc.20222—
+2K201682RIST Radial Access CatheterRist Neurovascular, Inc.20202—
+2K191664SelectFlex 072 Neurovascular Access SystemQ'Apel Medical20192—
+3K253032AXS Lift Intracranial Base CatheterStryker Neurovascular20260—
+3K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+3K234074Next Generation Access CatheterBalt USA, LLC20241—
+3K211893SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc.20211—
+4K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+4K254223Next Generation 088 CatheterBalt USA, LLC20260—