FDA 510(k) Applications Submitted by phenox Limited

FDA 510(k) Number Submission Date Device Name Applicant
K222848 09/21/2022 pRESET Thrombectomy Device phenox Limited
K191687 06/24/2019 pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire phenox Limited
K231539 05/30/2023 pRESET LITE Thrombectomy Device phenox Limited
K242676 09/06/2024 pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device phenox Limited


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact