FDA 510(k) Application Details - K234115

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K234115
Device Name	Catheter, Percutaneous
Applicant	Alembic, LLC 627 National Avenue Mountain View, CA 94539 US Other 510(k) Applications for this Company
Contact	Lisa Yen Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2023
Decision Date	03/15/2024
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	Y
Expedited Review