FDA 510(k) Application Details - K243601

Device Classification Name	Catheter, Thrombus Retriever   More FDA Info for this Device
510(K) Number	K243601
Device Name	Catheter, Thrombus Retriever
Applicant	Route 92 Medical, Inc. 155 Bovet Road Suite 100 San Mateo, CA 94402 US Other 510(k) Applications for this Company
Contact	Kirsten Valley 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	11/21/2024
Decision Date	05/19/2025
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