AngioVac F18 85

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

AngioDynamics, Inc.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiovac F18 85.

Pre-market Notification Details

Device IDK212386
510k NumberK212386
Device Name:AngioVac F18 85
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant AngioDynamics, Inc. 603 Queensbury Ave Queensbury,  NY  12804
ContactKasey E. Newcomb
CorrespondentKasey E. Newcomb
AngioDynamics, Inc. 603 Queensbury Ave Queensbury,  NY  12804
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-02
Decision Date2021-09-30

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