FDA 510(k) Application Details - K243297

Device Classification Name	More FDA Info for this Device
510(K) Number	K243297
Device Name	APRO 70 Swift Catheter
Applicant	Alembic, LLC 627 National Avenue Mountain View, CA 94043 US Other 510(k) Applications for this Company
Contact	Lisa Yen 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	10/18/2024
Decision Date	01/14/2025
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
Expedited Review