AngioDynamics, Inc. Soft-Vu And Mariner Angiographic Catheters

Catheter, Intravascular, Diagnostic

AngioDynamics, Inc.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics, Inc. Soft-vu And Mariner Angiographic Catheters.

Pre-market Notification Details

Device IDK173762
510k NumberK173762
Device Name:AngioDynamics, Inc. Soft-Vu And Mariner Angiographic Catheters
ClassificationCatheter, Intravascular, Diagnostic
Applicant AngioDynamics, Inc. 603 Queensbury Avenue Queensbury,  NY  12804
ContactTeri Juckett
CorrespondentTeri Juckett
AngioDynamics, Inc. 603 Queensbury Avenue Queensbury,  NY  12804
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-11
Decision Date2018-07-18
Summary:summary

NIH GUDID Devices

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