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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
510(k) Number K231539
Device Name pRESET LITE Thrombectomy Device
Applicant
phenox Limited
Kamrick Court, Ballybrit Business Park,
Galway,  IE H91XY38
Applicant Contact Rachel McDaid
Correspondent
phenox Limited
Kamrick Court, Ballybrit Business Park,
Galway,  IE H91XY38
Correspondent Contact Rachel McDaid
Regulation Number882.5600
Classification Product Code
POL  
Subsequent Product Code
NRY  
Date Received05/30/2023
Decision Date 10/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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