Phenox Limited

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DeviceFebruary 28, 2025
K231539pRESET LITE Thrombectomy DeviceOctober 21, 2023
K222848pRESET Thrombectomy DeviceJanuary 20, 2023
K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WireOctober 9, 2019