510(k) Report

Devices descending from K150366

6 later devices reach SOFIA 6F Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231179Slinky CatheterAnoxia Medical, Inc.20230—
+1K214024SOFIA 88 CatheterMicroVention, Inc.20220—
+1K213065Distal Access CatheterGuangzhou Easycess Medical Co.,Ltd20220—
+1K201682RIST Radial Access CatheterRist Neurovascular, Inc.20202—
+2K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+3K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—