510(k) Report

Devices descending from K191551

6 later devices reach RIST Cath Radial Access Long Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+1K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc.20232—
+1K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+2K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+2K253975Radical 6F Access CatheterMaduro Medical, Inc.20260—
+2K243577Radical the Dude 8F Guide CatheterMaduro Medical, Inc.20250—