AlphaVac Multipurpose Mechanical Aspiration (MMA) System

Aspiration Thrombectomy Catheter

AngioDynamics, Inc.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Alphavac Multipurpose Mechanical Aspiration (mma) System.

Pre-market Notification Details

Device IDK211081
510k NumberK211081
Device Name:AlphaVac Multipurpose Mechanical Aspiration (MMA) System
ClassificationAspiration Thrombectomy Catheter
Applicant AngioDynamics, Inc. 603 Queensbury Ave Queensbury,  NY  12804
ContactKasey E Newcomb
CorrespondentKasey E Newcomb
AngioDynamics, Inc. 603 Queensbury Ave Queensbury,  NY  12804
Product CodeQEZ  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-12
Decision Date2021-06-04

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