FDA 510(k) Application Details - K250012

Device Classification Name	Catheter, Thrombus Retriever   More FDA Info for this Device
510(K) Number	K250012
Device Name	Catheter, Thrombus Retriever
Applicant	Perfuze Ltd. Unit 6, Galway Business Park Dangan Galway H91 W7CP IE Other 510(k) Applications for this Company
Contact	Anne-Marie Gannon Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	NRY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2025
Decision Date	02/26/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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