FDA 510(k) Application Details - K241221

Device Classification Name	Catheter, Thrombus Retriever   More FDA Info for this Device
510(K) Number	K241221
Device Name	Catheter, Thrombus Retriever
Applicant	Cerenovus Inc. 6303 Waterford District Drive,Suites 215 & 315 Miami, FL 33126 US Other 510(k) Applications for this Company
Contact	Cara Feely 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	05/01/2024
Decision Date	10/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review