510(k) Report

Devices descending from K222848

2 later devices reach pRESET Thrombectomy Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePhenox Limited20250—
+1K231539pRESET LITE Thrombectomy DevicePhenox Limited20231—