FDA 510(k) Application Details - K213388

Device Classification Name	More FDA Info for this Device
510(K) Number	K213388
Device Name	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Applicant	AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12804 US Other 510(k) Applications for this Company
Contact	Kasey E. Newcomb Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2021
Decision Date	04/04/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review