pRESET Thrombectomy Device— 510(k) K222848

Substantially Equivalent

Phenox Limited

FDA 510(k) clearance K222848 for pRESET Thrombectomy Device, Substantially Equivalent on 2023-01-20. Applicant: Phenox Limited.

Clearance details

Applicant: Phenox Limited
Product code: Code POL
Advisory panel: Neurology
Date received: 2022-09-21
Decision date: 2023-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

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