FDA 510(k) Application Details - K211081

Device Classification Name	More FDA Info for this Device
510(K) Number	K211081
Device Name	AlphaVac Multipurpose Mechanical Aspiration (MMA) 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	04/12/2021
Decision Date	06/04/2021
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