AngioDynamics 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 Mariner Angiographic Catheters.

Pre-market Notification Details

Device IDK151724
510k NumberK151724
Device Name:AngioDynamics Mariner Angiographic Catheters
ClassificationCatheter, Intravascular, Diagnostic
Applicant ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
ContactTeri Juckett
CorrespondentTeri Juckett
ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-26
Decision Date2015-10-14
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.