pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device— 510(k) K242676

Substantially Equivalent

Phenox Limited

FDA 510(k) clearance K242676 for pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device, Substantially Equivalent on 2025-02-28. Applicant: Phenox Limited.

Clearance details

Applicant
Phenox Limited
Product code
Code POL
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Galway, IE
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