FDA 510(k) Application Details - K240529

Device Classification Name	More FDA Info for this Device
510(K) Number	K240529
Device Name	8F Modified Sheath System
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	More FDA Info for this Regulation Number
Classification Product Code	QJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2024
Decision Date	10/02/2024
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
Expedited Review