510(k) Report

Devices descending from K212838

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243593AXS Lift Intracranial Base CatheterStryker Neurovascular20251—
+1K240746Neurovascular Access System FamilyQ'Apel Medical, Inc.20240—
+1K230322SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc.20230—
+1K221822BENCHMARK BMX81 Access SystemPenumbra, Inc.20222—
+2K253032AXS Lift Intracranial Base CatheterStryker Neurovascular20260—
+2K234074Next Generation Access CatheterBalt USA, LLC20241—
+3K254223Next Generation 088 CatheterBalt USA, LLC20260—