510(k) Report

Devices descending from K162539

9 later devices reach Solitaire 2 Revascularization Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222848pRESET Thrombectomy DevicePhenox Limited20232—
+1K181807Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20192—
+1K181186Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20183—
+1K181060Solitaire 2 and Solitaire Platinum Revascularization DeviceMedtronic Neurovascular20180—
+2K242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePhenox Limited20250—
+2K231539pRESET LITE Thrombectomy DevicePhenox Limited20231—
+2K203358Solitaire X Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20210—
+2K193576Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20200—
+2K183022Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20192—