510(k) Report

Devices descending from K083343

39 later devices reach Headway 17 Microcatheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172014Wedge MicrocatheterMicroVention, Inc.20183—
+1K122684Reverse Medical MicrocatheterReverse Medical Corporation20122—
+1K121785Scepter C Occlusion Balloon CatheterMicroVention, Inc.20122—
+1K120917Headway Duo MicrocatheterMicroVention, Inc.201212—
+1K101542Headway 17 Advanced MicrocatheterMicroVention, Inc.201031
+1K093160Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc.200919—
+2K254071p17 XR MicrocatheterWallaby Medical20260—
+2K232542Wedge XL Delivery CatheterMicroVention, Inc.20240—
+2K230609NG Delivery CatheterBalt USA, LLC20231—
+2K203842Bendit21 MicrocatheterBend IT Technologies, Ltd.20221—
+2K182487CerusEndo MicrocatheterCerus Endovascular, Inc.20190—
+2K182829Scepter Mini Occlusion Balloon CatheterMicroVention, Inc.20190—
+2K183045Eclipse 2LBalt USA, LLC20190—
+2K162565VIA 17 MicrocatheterSequent Medical, Inc.20171—
+2K150894VIA 21 MicrocatheterSequent Medical, Inc.20152—
+2K131482Sofia Distal Access CatheterMicroVention, Inc.201311—
+2K130858Reverse Medical MicrocatheterReverse Medical Corporation20131—
+2K110813Headway 27 MicrocatheterMicroVention, Inc.20118—
+3K252213Bendit17 MicrocatheterBend IT Technologies, Ltd.20250—
+3K252569Carrier XL Delivery CatheterBalt USA, LLC20250—
+3K213065Distal Access CatheterGuangzhou Easycess Medical Co.,Ltd20220—
+3K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc.201903
+3K182602SOFIA EX Intracranial Support CatheterMicroVention, Inc.20192—
+3K171268Reverse 021 Micro Catheter, Reverse 027 Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20170—
+3K150366SOFIA 6F CatheterMicroVention, Inc.20156—
+3K142449Headway 27 MicrocatheterMicroVention, Inc.20155—
+3K142014Sofia Distal Access CatheterMicroVention, Inc.20147—
+4K231179Slinky CatheterAnoxia Medical, Inc.20230—
+4K230775SOFIA EX Intracranial Support CatheterMicroVention, Inc.20231—
+4K214024SOFIA 88 CatheterMicroVention, Inc.20220—
+4K213314CerusEndo Microcatheter (027)Cerus Endovascular, Inc.20220—
+4K201682RIST Radial Access CatheterRist Neurovascular, Inc.20202—
+4K192625PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company20193—
+5K254046BosCATH Support CatheterSonorous NV, Inc.20260—
+5K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+5K231600SENDERO MicrocatheterOkami Medical, Inc.20232—
+6K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+6K240384SENDERO MicrocatheterOkami Medical, Inc.20241—
+7K242644SENDERO MAX Delivery CatheterOkami Medical, Inc.20240—