510(k) Report

Devices descending from K131482

11 later devices reach Sofia Distal Access Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213065Distal Access CatheterGuangzhou Easycess Medical Co.,Ltd20220—
+1K182602SOFIA EX Intracranial Support CatheterMicroVention, Inc.20192—
+1K150366SOFIA 6F CatheterMicroVention, Inc.20156—
+1K142014Sofia Distal Access CatheterMicroVention, Inc.20147—
+2K231179Slinky CatheterAnoxia Medical, Inc.20230—
+2K230775SOFIA EX Intracranial Support CatheterMicroVention, Inc.20231—
+2K214024SOFIA 88 CatheterMicroVention, Inc.20220—
+2K201682RIST Radial Access CatheterRist Neurovascular, Inc.20202—
+3K254046BosCATH Support CatheterSonorous NV, Inc.20260—
+3K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+4K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—