Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact